Form 7-A Data KPK (List 2) M0062601490 22 F (7.4 mm) X17cm M0062601480 20 F (6.7 mm) X 17 cm M0062601470 18 F (6.1 mm) X 17 cm M0062601520 26 F (8.8 mm) X 17 cm M0062601460 16 F (5

"Following is the provisional list of applications received for registration of products on FORM-7A with the Division of Medical Devices & Medicated Cosmetics, Drug Regulatory Authority of Pakistan, Islamabad under provision of SRO 32(I)/2018 dated 16-01-2018. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application.

Disclaimer:

The contents of this list shall not be used as reference for any purpose including litigation, claim, right, research, citation, statistical analysis, etc and are for information only. Errors and omissions are accepted and at provisional stage the DRAP shall not be responsible for any legal claim and liability"

APPLICATION FOR THE GRANT OF REGISTRATION OF CLASS B, C & D MEDICAL DEVICE

FORM‐7A KHYBER PAKHTUNKHWA

S. No Name and Addresses of Establishment

Manufacture Details Name of Medical Device with Sizes/Class/Shelf Life

Brief Description R &I Detail

1. M/s Ferozsons Laboratories Ltd P.O Fersozsons, Amangarh, Nowshera (KPP) Pakistan 00120

Legal Manufacturer: Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA.

Manufacturing sites: Boston Scientific Corporation 2546 First Street, Propark, El Coyol, Alajuela, COSTA RICA 20904. FSC: FDA. US. Food & Drug

Valif till: 7th Feb. 2021

Zebra™ Guidewaire (Gastro‐urological guidewire) M0066701151 08714729191278 0.038” X 150cm/ Angle Tip M0066701131 08714729191261 0.035” X 150cm/ Angle Tip M0066701121 08714729191254 0.035” X 150cm/ Straight Tip M0066701141 08714729155232 0.038” X 150cm/ Straight Tip M0066701081 08714729191216 0.025” X 150cm/ Straight Tip M0066701091 08714729191223 0.025” X 150cm/ Angle Tip M0066701101 08714729191230 0.032” X 150cm/ Straight Tip

The Zebra Urological Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures. These guide wires are not intended for coronary artery, vascular or neurological use.

25070‐R&I 25.11.2019

(1/3)

Rs. 25,000

68‐KP‐DD(MD) 26.11.19

M0066701111 08714729191247 0.032” X 150cm/ Angle Tip Class: B Shelf Life:36th Months



Manufacturing sites: Boston Scientific Corporation 2546 First Street, Propark, El Coyol, Alajuela, COSTA RICA 20904. FSC: FDA. US. Food & Drug Valif till: 7th Feb. 2021

Sensor™ Nitinol Wire with Hydrophilic Tip (Gastro0urological guidewire, single‐use)

M0066703121 08714729257349 0.038” X 150cm/Straight Tip Dual Flex M0066703011 08714729302612 0.035” X 150cm/Angle Tip Dual Flex M0066703021 08714729302629 0.038” X 150cm/Angle Tip Dual Flex M0066703051 08714729302650 0.035” X 150cm/ Straight Tip M0066703061 08714729302667 0.035” X 150cm/Angle Tip M0066703081 08714729302681 0.035” X 150cm/ Straight Tip Dual Flex M0066703101 08714729257325 0.038” X 150cm/Angle Tip M0066703091 08714729257318 0.038” X 150cm/ Straight Tip CLASS: B Shelf Life 36th Months

Sensor Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures. These Guidewires are not intended for coronary artery, vascular or neurological use

25070‐R&I 25.11.2019

(2/3)

Rs. 25,000

69‐KP‐DD(MD) 26.11.19



Manufacturing sites: Boston Scientific Corporation 2546 First Street, Propark, El Coyol, Alajuela, COSTA RICA 20904. FSC: FDA. US. Food & Drug Valif till: 21st January,2021

UroMax Ultra™ Balloon Dilatation Catheter (Ureteral Dilatation Catheter) M0062251000 08714729341109 12Fr (4mm) x 4cm M0062251010 08714729341116 15Fr (5mm) x 4cm M0062251020 08714729341123 18Fr (6mm) x 4cm M0062251030 08714729341130 21Fr (7mm) x 4cm M0062251040 08714729341147 24Fr (8mm) x 4cm M0062251050 08714729341154 30Fr (10mm) x 4cm M0062251060 08714729341161 12Fr (4mm) x 6cm M0062251070 08714729341178 15Fr (5mm) x 6cm M0062251080 08714729341185 18Fr (6mm) x 6cm M0062251090 08714729341192 21Fr (7mm) x 6cm M0062251100 08714729341208 24Fr (8mm) x 8cm M0062251110 08714729341222 30Fr (10mm) x 8cm M0062251150 08714729341239 12Fr (4mm) x 10cm M0062251160 08714729341246 15Fr (5mm) x 10cm M0062251170 08714729341253 18Fr (6mm) x 10cm M0062251180 08714729341260 21Fr (7mm) x 10cm

Class: B

Uromax UltraTM Balloon Dilatation Catheters are recommended for dilatation of the urinary tract.

25070‐R&I 25.11.2019

(3/3)

Rs. 25,000

70‐KP‐DD(MD) 26.11.19

Shelf Life: 36th Months

4. M/s. Hashir Surgical Services, Office No.5, 2nd Floor, Syed’s Tower, University Road, Peshawar. (ELI‐00075)

Legal Manufacturer: M/s. USM Healthcare Medical Devices Factory JSC Manufacturer Site: Lot I‐4b‐1.3, N3 Street, Saigon Hi‐tech Park, Long Thanh My Ward, Ho Chi Minh City, Vietnam,

FSC: Vietnam,

Date of Issue 23/03/2019 Valid till 22/03/2022.

Favocath IV Catheter with Injection Stopper Code: G‐14‐G‐16‐G‐18 G‐20‐G‐22‐G‐24 Class B Shelf Life: 5 years.

I.V Catheter provides access to a vein of a patient in order to sample blood, administer fluids or nutrition, for the continuous use of not more than seven days.

26288‐R&I 06.12.2019

Rs. 25,000

71‐KP‐

DD(MD) 6.12.2019


Legal Manufacturer: M/s. USM Healthcare Medical Devices Factory JSC Manufacturer Site: Lot I‐4b‐1.3, N3 Street, Saigon Hi‐tech Park, Long Thanh My Ward, Ho Chi Minh City, Vietnam,

FSC: Vietnam,

Date of Issue 23/03/2019 Valid till 22/03/2022.

Favocath IV Catheter Small Wings with Injection Stopper (I.V Cannula with Catheter+ injection Stopper) Code: G‐14‐ G‐16‐ G‐18‐ G‐20‐ G‐22‐ G‐22 Class‐B Shelf Life 5 years

The product is an Intravenous Catheter that is inserted into a vein for supply medications or nutrients directly into the bloodstream. I.V Catheter provides access to a vein of a patient in order to sample blood, administer fluids or nutrition for the continuous use of not more than seven days.

26288‐R&I 06.12.2019

Rs. 25,000

72‐KP‐

DD(MD) 6.12.2019


Legal Manufacturer

Jiangxi Fenglin Appliances Co., Ltd, Fulin Road Fuzhou City Jiangxi Province china FSC: China

Date of issue: 16th Marth 2015

Bio Soft Infusion Y‐Site

(Infusion Set)

Code (not mentioned)

Class: B Shelf Life: 5 years

Infusion Set 26288‐R&I 06.12.2019

Rs. 25,000

73‐KP‐

DD(MD) 6.12.2019


Legal Manufacturer Jiangxi Fenglin Appliances Co., Ltd, Fulin Road Fuzhou City Jiangxi Province china FSC: China

Date of issue: 16th Marth 2015

Flow Cath IV Cannula Small Wings with Heparin Cap.

(IV Cannula withCatheter) (Gauge 14, 16, 18, 20, 22, 24, 26) Class: B

Shelf Life: 5 years

(IV Cannula with Catheter 26288‐R&I 06.12.2019

Rs. 25,000

74‐KP‐

DD(MD) 6.12.2019


Legal Manufacturer Jiangxi Fenglin Appliances Co., Ltd, Fulin Road Fuzhou City Jiangxi Province china FSC: China Date of issue: 16th Marth 2015

Flow Cath IV Cannula Injection Port, Wings with Suturing holes and Heparin Cap IV Cannula with Catheter Gauge 14, 16, 18, 20, 22, 24, 26) Class: B Shelf Life: 5 years

(IV Cannula with Catheter) 26288‐R&I 06.12.2019

Rs. 25,000

75‐KP‐

DD(MD) 6.12.2019

9. M/s IBS Pharmaceuticals & Generl Order Supply Business. Haji Gulam Saeed Medicine Market Namak Mandi Peshawar Gulab Khana Peshawar. ELI…..

High Technology, INc (HTI) 20 Alice Agnew Dr., North Attleboro, MA 02763 USA FSC: US FDA 16TH august,2019

HTI (HTI BIOCHEM FC‐360 CHEMISTRY ANALYZER)

Code…

Class: B Shelf Life: Not applicable

Automated clinical chemistry analyzer, utilizes photometer to determine concentration of certain substances on human serum. Used for screening serum smaples.

19979 R&I 07.10.19

(1/2)

25,000/‐

76‐KP‐P‐DD(MD) 23.11.19

10. M/s IBS Pharmaceuticals & Generl Order Supply Business. Haji Gulam Saeed Medicine Market Namak Mandi Peshawar Gulab Khana Peshawar. ELI…..

High Technology, INc (HTI) 20 Alice Agnew Dr., North Attleboro, MA 02763 USA FSC: US FDA 16TH august,2019

Form 7‐A not found 19979 R&I 07.10.19

(2/2)

25,000/‐

77 ‐KP‐P‐DD(MD) 23.11.19

11. M/s Safi Brothers, Office S‐22, Second Floor Clock Tower, Shamsi Road, Maradn KPK ELI‐00337

Legal Manufacturer Ningbo Yingmed Medical Instruments Co., Ltd Yingsheng Building, No, 456 Tai’an Road Southern Business Zone, 315199 Ningbo, China FSC: China Date of issue09.02.2018

YINGMED (I.V CANNULA with Wings and Heparin Cap ( 14G‐16G‐18G‐20G‐22G‐24G) Class: B Shelf life: 5 years

I.V Cannula is used for insertion into body, for delivery or removal of fluid or gathering samples.

30541‐ R&I 16.01.2020)

25,000/‐

78‐KP‐P‐DD(MD)

16.01.2020


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA

Manufactuign Sites: Boston Scientific Corporation 2546 First Street Propark ELI Coyol Alajuela Costa Rica 20904 .

FSC: U.S. FOOD & DRUG Valid till: 15th April, 2021

SpyBite Biiopsy Forceps (Flexible Endotherapy Biopsy Forceps, Single‐use) M00546270‐08714729764458 ‐1.0MMM/286CM

Class‐ B Shelf Life: 36 months

The Spy Bite Biopsy Forceps are indicated for tissue acquisitonin the pancreaticobilary system

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA Manufactuign Sites: Boston Scientific Corporation 780 Brookside Drive Spencer, IN USA . FSC: U.S. FOOD & DRUG Valid till: 25 June,2020

Acquire Endoscopic UltrasoundFine Needle Biopsy (FNB) Device

Needles M00555540‐08714729931782 22ga,0.72mm M00555541‐08714729931843 22ga,0.72mm, Box5 M00555560‐08714729931805 25ga,0.52mm, M00555561‐08714729931867 25ga,0.52mm, Box5

Class‐ B

Shelf Life: 36 months

The Acquire ™ devices are designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

29129‐ R&I 02.01.2020)

25,000/‐

80‐KP‐P‐DD(MD) 16.01.2020



Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

(Needle)

M00555500‐08714729848141 19ga/0.10mm M00555510‐08714729848158 20ga/0.72mm M00555520‐08714729848165 25ga/0.52mm M00555501‐08714729848714 19ga/1.10mm, Box 5 M00555511‐08714729848721 22ga/ 7.72mm, Box 5 M00555521‐08714729848738 25ga/0.52mm,Box 5 Class: B

Shelf LIFe: 36 months

Expect ™ devices are designed to smaple targeted submucosal and extramural gastrointestinal lesions throught the accessory channel of a curvilinear echoendoscope.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA Manufactuign Sites: Boston Scientific Corporation wo Scimed Place Maple Grove FSC: U.S. FOOD & DRUG Valid till: 3.5.2020

Guidezilla ™ II Guide Extension Catheter Vascular Guide catheter, single‐use H7493933515060‐08714729939450 GuIDE Extension Catheter, 6F,150cm H7493933515070‐08714729939474 GuIDE Extension Catheter, 7F,150cm H7493933515080‐08714729939481 GuIDE Extension Catheter, 8F,150cm

Class‐B Shelf Life: 24 months

The Guidezilla ™ Guide Extensiion Catheter is intended to be used in conjuction with guide catheters to access discrete regions of the coronary and /or peripheral vasculature, and to facilitate placemnt of interventional devices. Guidezilla is not intended for use in the cerebral vasculature. The device ae provided non‐pyrogenic, sterile, and intended for one procedure only.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA Manufactuign Sites: Boston Scientific Corporation 780 Brookside Drive Spencer, IN USA . FSC: U.S. FOOD & DRUG Valid till: 25th June,2020

Trapezoid RX Wireguided Retrieval Baskets (Biliary Stone Retrieval Basket M00510860 08714729296379 1.5cm M00510870 08714729296386 2.0cm M00510880 08714729296393 2.5cm M00510890 08714729296409 3.0cm Class‐B

The Trapezoid RX Wireguided Retrieval Basket is indicated for endoscopic crushing and removal of biliary calfuli.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020

Shelf Life: 12 Months


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA Manufactuign Sites: Boston Scientific Corporation Business and Technology Park Model Farm Road Cord Ireland FSC: Ireland Valid till: 22nd Sep.2022

WATCHDOG ™ Hemostasis Valve Kit (Stopcock) H 74939343A020 WATCHDOG Hemostasis Valve Kit (Single‐PK) H 74939343A021 WATCHDOG Hemostasis Valve Kit (20‐PK) Class‐B Shelf Life: 24 Months

The WATCHDOG ™ Hemostasis Valve is intended to maintain hemostasis during diagnostic/ interventional procedures. The WATCHDOG Hemostasis. Valve is indicated for maintaining a seal aroung diagnostic/interventinal devices with combined outer diametrs of up to 8F {0.105 in (2,67 mm) during diagnostic/interventional procedures.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020



Speedband Superview Super 7 Oesophageal endoscopic Ligator, single‐use/ Haemorrhoid Ligator M00542250‐ 08714729201953 Box 1 M00542251‐ 08714729201960 Box 2 M00542253‐ 0871472920504832 Box 4 Class‐B Shelf Life: 12 Months

The Speedband superview super 7 Band Ligator is used for endoscopic ligation of esophageal various and anorectal hemorrhoids.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020



SpyScope DS Access and Delivery Catheter Flexiblevideo choledochoscope M00546600‐08714729863236 Class‐B Shelf Life 24 Months

The SpyGlasss DS Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico‐biliary system including the hepatic ducts. .

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020



Percuflex Biliary Stent Prosthesis, internal, Stent, Non‐Vascular ………………………. Class‐C Shelf Life: 36 months

The devices are intended for use in the treatment of biliary strictures.

29129‐ R&I 02.01.2020)

50,000/‐


16.01.2020


Legal Manufacturer Boston scientific Corporation 300, Boston scientific way Marlborough, MA Manufactuign Sites: Boston Scientific Corporation Business and Technology Park Model Farm Road Cord Ireland FSC: Ireland Valid till: 21 April,2021

CRE Pro Wireguided Esophageal/Pyloric/Colonic/ Biliary Balloon Dilatation Catheter Code: …………… Gasrointestinal Dilation Balloon Catheter Class‐B Shelf Life:

Esophageal/Plyoric/Colonic/Biliary codes. The CRE PRO Wireguided Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate stricutures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

29129‐ R&I 02.01.2020)

25,000/‐


16.01.2020

22. Hashir Surgical Services Office No.16, Street 1, F‐2, Phase 6, Hayatabad, Peshawar.

Office No.05, 2nd Floor, Syed’s Tower, University Road, Peshawar. House No.2, Street No.1, Gulshan Colony, GT Road, Peshawar ELI: 00075,

Legal Manufacturer USM Healthcare Medical Devices Factory Joint Stock Company Manufacturer Site Lot‐4b‐1‐3, N3 Street, SaigonHi‐tech Park, Long Thanh My Ward, District 9, Ho Chi Minh City, Vietnam FSC: Vietnam Date of Issue 10th Nov.2019

UStopper Injection Stopper Class‐B Shelf Life; 5 years

Ustopper Injection stopper is used to prevent blood flowing out of the catheter’s port or other ctheters with standard female conector, which need to be protected and kep a sterile environment when temporarily disconnected from the other device.

30643‐R&I 17.01.2020

50,000/‐ 89‐KP‐

DD(MD) 17.01.2020


Legal Manufacturer: Boston Scientific Corporation, 300, Boston Scientific Way, Marlborough, MA 01752 USA. Manufacturing sites:

Boston Scientific Corporation 780 Brookside Drive Spencer, In USA FSC: USA Valid till: 2nd April,2021

Zero Tip ™ Nitinol Stone Retrival Basket (Urinary Stone Retreval Basket, Single Use)

Code: MOO63901000‐08714729341994

M0063901010‐08714729342007 M0063901020‐08714729342014 M0063901030‐08714729342021 M0063901050‐08714729469643 M0063901040‐08714729469636

Class: b Shelf Life: 36th months

The stone Retrieval Basket is intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects

17‐R&I 03.02.2020

25,000/‐ 90‐KP‐

DD(MD) 3.02.2020



Ballybrit Business Park Galway, Ireland FSC: USA Valid till: 21st January,2021

Nephromax ™ High Pressure Nephrostomy Balloon Catheter (Nephrostomy Catheter) M0062101170‐M0062101400‐ M0062101420‐M0062101440

Class: B Shelf Life: 36th months

The NephroMax High Pressure Nephrostomy Balloon catheters are recommended for dilatationof the nephrostomy tract.

16‐R&I 03.02.2020

25,000/‐ 91‐KP‐

DD(MD) 3.02.2020



2546 First Street Propark, EI Coyol Alajuela COSTA RICA FSC: USA Valid till: 7TH Feb,2021

Percuflex™ Plus Ureteral Stent (Polymeric Ureteral Stent) Code: M0061751950‐ M0061751960‐ M0061751970‐ M0061751980‐ M0061751990‐ M0061752500‐ M0061752530‐ M0061752510‐‐ M0061752840‐ M0061752830‐ M0061752700‐ M0061752540‐ M0061752550‐ M0061752600 Class‐C Shelf Life: 36t months

The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.

11‐R&I 03.02.2020

25,000/‐ 92‐KP‐

DD(MD) 3.02.2020

26. Part of Percuflex™ Plus Ureteral Stent (Polymric Ureteral Stent)

. 11‐R&I 03.02.2020

92‐KP‐

DD(MD) 3.02.2020



Boston Scientiifc Corporation 780 Brooksside Drive Spencer IN USA 47460 FSC: USA Valid till: 2 April,2021

Advantage ™ system Transvaginal MID‐Urethral Sling (Stress urinary icontinence urogynecological surigical mesh, synthetic polymer) M0068502000‐08717729470274 Class‐C Shelf Life: 36 months

The Meshimplant is intened for use as a sub‐urethral sling for the treatment of stress urinary incontinence resulting form urethral hypermobility and /or instrinsic spheinter deficiency.

15‐R&I 03.02.2020

50,000/‐ 93‐KP‐

DD(MD) 3.02.2020



Boston Scientiifc Corporation 780 Brooksside Drive Spencer IN USA 47460 FSC: USA Valid till: 25 june,2020

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (Endoscopic Needle, General purpose, single use) Code: M00558220 ‐08714729861409 M00558221 ‐08714729861430 M00558250 ‐08714729861416 M00558251 ‐08714729861447 M00558250 08714729861461 M00558251 08714729861485 Class‐B Shelf Life: 36 months

The Expect ™ Pulmonary Endobronchial Ultroasound Transbronchial Aspiration Needle is designed to beused with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.

13‐R&I 03.02.2020

25,000/‐ 94‐KP‐

DD(MD) 3.02.2020



Boston Scientiifc Corporation 780 Brookside Drive Spencer IN USA 47460 FSC: USA Valid till: 2nd April, 2021

Navigator ™ Ureteral Access Sheath set (Endoscopic‐acces Dilator, single‐ use Code: M0062502031‐ M0062502020‐ M0062502011‐ M0062502000‐ M0062502060‐ M0062502040‐ M0062502051‐ M0062502111‐ M0062502100‐ M00625020291‐ M0062502080‐ M0062502071 Class: B Shelf life 24 Months

The Navigator Ureteral AccessSheath is indicated for use in endoscopic o procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the4 urinary tract.

18‐R&I 03.02.2020

25,000/‐ 95‐KP‐

DD(MD) 3.02.2020



Boston Scientiifc Corporation 2546 First Street Propark, EI Coyol Alajuela COSTA RICA FSC: USA Valid till: 15 April, 2021

MicroKnife XL Triple Lumen Needle Knife Endoscopic Electrosurgical electrode, monopolar, single‐use Code: M00532810 08714729172017 5.5F Class: B Shelf LIfe

The MicroKnife XL sphincterotome is capable of accepting an 0.035 in (0.89 mm) guidewire in one open channel while simultaneously injecting and /or cutting in the other lumens. No stylet is necessary for scope passage. The MicriKnife XL Sphincterotome may beplaced with or without the aid of a guidewire. When connected to a monopolar current, the MicroKnife XL Sphincterotome may beused to incise the Papilla of Vater and /or the Sphincter of Oddi.

12‐R&I 03.02.2020

25,000/‐ 96‐KP‐

DD(MD) 3.02.2020



Boston Scientiifc Corporation Teo Scimed Place Maple Grove MN USA FSC: USA Valid till: 7 March,2021

ACUITY ™ Pro Guide Catheter Catheter, Coronary, Guide Model: 8100‐8101‐8102‐8104‐8105‐8106‐8107‐8108‐8109‐8110‐8112‐8113‐8114‐8115‐ 8116‐8117‐8118‐8119‐ Class‐ D Shelf Life: 24 months

The Acuity ™ Lead Delivery System Catheters are intended to access the coronary venous system and may be used in dual‐ catherter delivery,. The catheter serves as a conduit for the delivery of contrast medium and devices, including implatbale coronary venous leads, introduced into the coronary venous system. S

906‐R&I 10.02.2020

50,000/‐ 97‐KP‐

DD(MD) 10.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 780 Brookside Drive, Spencer, IN USA 47460 FSC:USA Date of issue ..03‐04‐2019 Valid till…02‐04‐2021

Amplatz Type Renal Sheath (Multi Purpose percutaneous drainage catheter) Codes: M0062601530 28 F (9.4

mm) X 17 cm M0062601510 24 F (8.1

mm) X 17 cm M0062601490 22 F (7.4

mm) X 17 cm M0062601480 20 F (6.7

mm) X 17 cm M0062601470 18 F (6.1

mm) X 17 cm M0062601520 26 F (8.8

mm) X 17 cm M0062601460 16 F (5 .3

The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access. The Amplatz Type Renal Sheath is used to maintain the nephrostomy tract opening, allowing smooth passage of surgical instrumentation through the nephrostomy tract. They are made of firm, radiopaque PTFE. The tapered tip is designed for atraumatic placement and ease of advancement over dilators or balloons. The Amplatz Type Renal Sheaths are available in 14F to 30F ID even sizes. The Sheaths are housed in a cello tube and then packaged in a Tyvek/Poly pouch. The sheaths are provided sterile,

1754‐R&I 18.02.2020

25,000/‐ 98‐KP‐

DD(MD) 18.02.2020

mm) X 17 cm M0062601450 14 F (4.7

mm) X 17 cm M0062601540 30 F (10.1

mm) X 17 cm M006900 1230 30 F (10.1

mm) X 20 cm Class : B Shelf Life : 4 years

for single use.


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 780 Brookside Drive, Spencer, IN USA 47460 FSC USA Date of issue ..26‐06‐2018 Valid till…25‐06‐2020

Interject Contrast Injection Therapy Needle Catheter Codes: M00518151 23ga/4mm/200cm M00518161 25ga/4mm/ 200cm M00518251 23ga/6rnm/200cm M00518261 25ga/6mm/ 200cm M00518 351 23ga/4mm/240cm M00518361 25ga/4mm/240cm Class : B Shelf Life : 3 years

The InterjectTM Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to: •introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system •aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures •control non‐variceal hemorrhage

1756‐R&I 18.02.2020

25,000/‐ 99‐KP‐

DD(MD) 18.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Lake Region Medical Limited BUTLERSLAND NEW ROSS, Wexford IRELAND FSC USA Date of issue ..04‐03‐2019 Valid till…03‐03‐2021

PTFE Urological Guidewires Codes: M0066201000 PTFE .038 Fixed

Core, Straight, 3 cm Flex M006620 1010 PTFE .038 Stiff

Bodied, Fixed Core. Strt M006620 1020 PTFE .038 Stiff

Bodied, Fixed Core, 3mm J M006620 1030 PTFE .038

Moveable Core, Straight M0066201050 PTFE .038 Fixed

Core, 15cm Flex, Bentson M0066201070 PTFE .025 Fixed

Core. Straight. 3 cm Flex M006620 1080 PTFE .025 Stiff

Bodies, Fixed Core, 3 cm Flex M0066201100 PTFE .035 Stiff

Bodies, Fixed Core, Strt M006620 1110 PTFE .035 Stiff

Bodies, Fixed Core, 3mm J M0066201200 PTFE .035 Fixed

Core, Straight, 3 cm Flex M0066201210 PTFE .035

Moveable Core, 3 mm J M0066201220 PTFE .038

Moveable Core, 3 mm J M0066201250 PTFE .035 Fixed

Core. 15cm Flex, Bentson M0066201300 PTFE .035

Moveable Core, Straight Class : B Shelf Life : 4 years

The PTFE coated Urological Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures. These guide wires are not intended for coronary artery, vascular or neurological use

1757‐R&I 18.02.2020

25,000/‐ 100‐KP‐DD(MD)

18.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston scientific Corporation 302 Parkway, Global Park, La Aurora, Heredia Costa Rica La Aurora Heredia Costa rica FSC: FDA U.S FOOD &DRUG Valif till: 7 March, 2021

ACUITY WHISPER VIEW™ Guide wire

Catheter Guidewire Model: 4640‐4641‐4642‐4643‐4647‐4648 Class‐D Shelf Life:L 24 months

The ACUITY Whisper View Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Venous vasculature.

907‐R&I 10.02.2020

50,000/‐ 101‐KP‐DD(MD)

18.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 780 Brookside Drive, Spencer, IN USA 47460 FSC FDA U.S FOOD &DRUG Date of issue ..03‐04‐2019 Valid till…02‐04‐2021

Products Name: ObtryxTM System Curved Transobturator Mid‐Urethral Sling Codes: M0068504000 Mesh Assembly and (2} Delivery Device s Class : C Shelf Life : 3 years

The mesh implant is intended for use as a sub‐urethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

907‐R&I 18.02.2020

50,000/‐ 102‐KP‐DD(MD)

18.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Manufacturing Site:… Boston Scientific Limited Ballybrit Business Park, Galway, Ireland FSC USA Valid tll : 6th September,2023

PROMUS Element™ Plus MONORAILTM Everolimus‐Eluting Coronary Stent System Codes: AS PER FSC Class : D Shelf Life : 2 years

Indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.

907‐R&I 18.02.2020

50,000/‐ 103‐KP‐DD(MD)

18.02.2020

38 M/s Ferozsons Laboratories Ltd P.O Fersozsons, Amangarh, Nowshera (KPP) Pakistan 00120

Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… PendraCare International B.V. Van der Waalspark 22 9351 VC Leek THE NETHERLANDS FSC NETHERLANDS Date of issue ..27‐09‐2019 Valid till…01‐11‐2023

Convey™ Guiding Catheter (Vascular guide catheter, 1. AL1.5 SH (SIDE HOLES)

Class : B Shelf Life : 3 years

The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems

2342‐R&I 24.02.2020

25,000/‐ 104‐KP‐DD(MD)

24.02.2020



Boston Sceintific Corporation 2546 First Street, Propark EI Coyol Alajuela, Costa Rica FSC: USA Valid till: 7 Feb,2021

Contour VL ™ Variable Length Ureteral Stent (Polymeric Ureteral Stent) Codes: M0061801550 4.8 F X 22-30

cm , Soft Percuflex™ Material

M0061801ꞏ560 6 F X 22-30 cm , Soft Percuflex™ Material

M0061801570 7 F X 22-30 cm, Soft PercuflexTM Material

Class : C Shelf Life : 3 years

Extrinsic compression of ureter • Ureteral obstruction • Ureteral trauma • Ureteral manipulation • Preparation for ureteral manipulation • Assistance with stone fragment passage

2343‐R&I 24.02.2020

50,000/‐ 104‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Limited Cashel Road CLONMEL, Tipperary IRELAND FSC USA Date of issue ..07‐06‐2019 Valid till…06‐06‐2021

Products Name: Tactra Malleable Penile Prosthesis Codes: 720080‐01 720081‐01 720082‐01 Class : C Shelf Life : 1 years

The Tactra Penile Prosthesis is a sterile, single‐use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation sur

2344‐R&I 24.02.2020

50,000/‐ 105‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC :FDA U.S FOOD &DRUG Date of issue.06‐04‐2018 Valid till…05‐04‐2020

Products Name: Programmer/Recorder/Monitor Codes: Model: 3120 Class : D Shelf Life : NA

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the associated product literature for the pulse generator being interrogated.

2350‐R&I 24.02.2020

50,000/‐ 106‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC :FDA U.S FOOD &DRUG Date of issue ..14‐01‐2016 Valid till…14‐01‐2021

Products Name: INGEVITY MRI Implantable Lead (Defibrillator/pacemaker Lead) Codes: Models: 7731,7732, 7735, 7736, 7740, 7741, 7742 Class : D Shelf Life : 2 years

Indications for use are identical for MRI and non‐MRI models within each fixation type. INGEVITY passive fixation leads are indicated for use as follows: • Intended for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator. INGEVITY active fixation leads are indicated for use as follows: • Intended for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.

2350‐R&I 24.02.2020

50,000/‐ 106‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC :FDA U.S FOOD &DRUG Date of issue ..30‐08‐2019 Valid till…29‐08‐2021

Products Name: ENDOTAK RELIANCE 4‐SITE (Defibrillator/pacemaker Lead) Codes: Modes: 262,263,272,273 Class : D Shelf Life : 2 years

The ENDOTAK RELIANCE 4‐SITE models provide pacing and rate‐sensing and deliver cardioversion and defibrillation shocks for ICD systems

2349‐R&I 24.02.2020

50,000/‐ 107‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:… Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC :FDA U.S FOOD &DRUG Date of issue ..30‐04‐2019 Valid till…29‐04‐2021

Products Name: ESSENTIO MRI Single Chamber Pacemakers (rate responsive) Codes: Model: L110 Class : D Shelf Life : 2 years

Boston Scientific Ingenio 2 pacemakers (ACCOLADE, ACCOLADE MRI, PROPONENT, PROPONENT MRI, ESSENTIO, ESSENTIO MRI, and ALTRUA 2) are clinically indicated for the treatment of the following conditions: • Symptomatic paroxysmal or permanent second‐ or third‐degree AV block; .

2338‐R&I 24.02.2020

50,000/‐ 108‐KP‐DD(MD)

24.02.2020

45 VOLUMN 1 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI MODELS L110

VOLUMN 2 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI‐ MODELS L110

VOLUMN 3 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI MODELS L110

2338‐R&I 24.02.2020

108‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC : FDA U.S FOOD &DRUG Date of issue..30‐04‐2019 Valid till…29‐04‐2021

Products Name: ESSENTIO MRI (dual Cchamber Pacemakers (rate responsive) Model: L111, L131

Class : D Shelf Life : 2 years

Boston Scientific Ingenio 2 pacemakers (ACCOLADE, ACCOLADE MRI, PROPONENT, PROPONENT MRI, ESSENTIO, ESSENTIO MRI, and ALTRUA 2) are clinically indicated for the treatment of the following conditions: • Symptomatic paroxysmal or permanent second‐ or third‐degree AV block; • modes are specifically indicated for treatment of the following: • Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; • VVI intolerance (i.e., pacemaker syndrome) in the bradycardia.

2345‐R&I 24.02.2020

50,000/‐ 109‐KP‐DD(MD)

24.02.2020

47 VOLUMN 2 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI MODELS L111,l131

___________________________________________________________________________________________________________ VOLUMN 3 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI MODELS L111,l131

________________________________________________________________________________________________________________

VOLUMN 4 OF 108‐(KP‐) VIDE Products Name: ESSENTIO MRI MODELS L111,l131

2345‐R&I 24.02.2020

50,000/‐ 109‐KP‐DD(MD)

24.02.2020


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC : FDA U.S FOOD &DRUG Date of issue ..30‐04‐2019 Valid till…29‐04‐2021

Products Name: VISIONIST X4 Codes: U228


Boston Scientific Ingenio 2 CRT‐Ps (VISIONIST, VISIONIST X4, VALITUDE, and VALITUDE X4) are clinically indicated for patients who have symptomatic Updated September 30, 2019 Page 3 of 6 congestive heart failure including left ventricular dysfunction and wide QRS; and/or one or more of the following conditions: • Symptomatic paroxysmal or permanent second‐ or third‐degree AV block;

2346‐R&I 24.02.2020

50,000/‐ 110‐KP‐DD(MD)

24.02.2020

49 VOLUMN 2 OF 10‐(KP‐) VIDE Products Name: VISIONIST X4 Codes: U228

VOLUMN 3 OF 108‐(KP‐) VIDE Products Name: VISIONIST X4 Codes: U228

VOLUMN 4 OF 108‐(KP‐) VIDE Products Name: VISIONIST X4 Codes: U228

2346‐R&I 24.02.2020

110‐KP‐DD(MD)

24.02.2020

50

M/s Ferozsons Laboratories Ltd P.O Fersozsons, Amangarh, Nowshera (KPP) Pakistan 00120

Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site:

Products Name: SUPPORTRAK Finishing Wire (Finishing Wire) Models: 6667,6668,6669

The SUPPORTRAK finishing wire is intended to aid in the placement of a Boston Scientific implantable coronary venous lead in the coronary venous vasculature.

2347‐R&I 24.02.2020

111‐KP‐DD(MD)

24.02.2020

Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC : FDA U.S FOOD &DRUG Valid till…28‐08‐2020

Class: D Shelf Life : 2 years

51


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 4100 Hamline Ave N Saint Paul, MN USA 55112 FSC : FDA U.S FOOD &DRUG Date of issue ..29‐08‐2018 Valid till…28‐08‐2020

Products Name: Acuity X4 Lead, defibrillator/pacemaker, implantable) Codes: Models: 4671, 4672, 4674, 4675, 4677, 4678


Intended for chronic, left‐ventricular pacing and sensing via the coronary venous system when used in conjunction with a compatible pulse generator.

2339‐R&I 24.02.2020

112‐KP‐DD(MD)

24.02.2020

52


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation

Products Name: EASYTRAK 2 (ndocardial Leads) Models: 4517, 4518, 4520, 4542, 4543, 4544 Class : D Shelf Life : 2 years

The Boston Scientific EASYTRAK 2 IS‐1 coronary venous pace/sense leads, Models 4542/4543/4544, are transvenous leads intended for chronic, left‐ventricular dual‐electrode pacing and sensing via the coronary veins when used in conjunction with a compatible Boston Scientific cardiac resynchronization therapy (CRT) heart failure device that accepts

2341‐R&I 24.02.2020

113‐KP‐DD(MD)

24.02.2020

4100 Hamline Ave N Saint Paul, MN USA 55112 FSC : FDA U.S FOOD &DRUG Valid till…28‐08‐2020

the IS‐1 connector.

53


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Limited Ballybrit Business Park, Galway, Ireland FSC Ireland Valid till…12‐04‐2023

Products Name: PROMUS Element™ Plus MONORAILTM Everolimus‐Eluting Coronary Stent System (Drug‐eluting coronary artery stent, non‐bioabsorbable –polymer‐coated) Codes: H7493918416400 PROMUS Element Plus MR / 16 mm x 4.00 mm

1. H7493918420400 PROMUS Element Plus MR / 20 mm x 4.00 mm



4. H7493918432400 5. Class : D

Shelf Life : 2 years

Indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease. This includes patients with acute myocardial infarction and patients with concomitant diabetes mellitus due to discrete de novo native coronary artery lesions. Also indicated to include treatment of the following patient and lesion subsets: coronary artery ostial lesions; unprotected left main coronary artery lesions; coronary artery total occlusion lesions; in‐stent restenosis in coronary artery lesions; coronary bifurcation lesions. The treated lesion length should be less than the nominal stent length (8mm, 12mm, 16mm, 20mm, 24mm, 28mm, 32mm and 38mm) with a reference vessel diameter of 2.25 mm ‐ 4.0 mm.

2340‐R&I 24.02.2020

114‐KP‐DD(MD)

24.02.2020

54

M/s Hashir Surgical Services 1. Office No.16, Street 1, F‐2,

Phase 6, Hayatabad, Peshawar.

2. Office No.05, 2nd Floor, Syed’s Tower, University Road, Peshawar. House No.2, Street No.1, Gulshan Colony, GT Road, Peshawar

ELI: 00075

Legal Manufacaturer: LR No.5025/1239 Msumarini‐Mombasa‐Malindi Rd P.O BOX 80713‐80100 Mombasa‐Kenya. FSC: Kenya Date of issue: 31st Decemberm2019

REVITAL CADY Auto Disable Syringes for immunization 0.5ml Class:B Shelf LIFe: 12 months

Auto Disable Syringes for immunization

1750‐R&I 18.02.2020

5,000/‐ 114‐P‐

DD(MD) 24.02.2020

55

M/s Hashir Surgical Services 3. Office No.16, Street 1, F‐2,

Phase 6, Hayatabad, Peshawar.

4. Office No.05, 2nd Floor, Syed’s Tower, University Road, Peshawar. House No.2, Street No.1, Gulshan Colony, GT Road, Peshawar

ELI: 00075

Legal Manufacaturer: LR No.5025/1239 Msumarini‐Mombasa‐Malindi Rd P.O BOX 80713‐80100 Mombasa‐Kenya. FSC: Kenya Date of issue: 31st Decemberm2019

REVITAL CADY Auto Disable Syringes for immunization 0.5ml Class:B Shelf LIFe: 12 months

Auto Disable Syringes for immunization

1750‐R&I 18.02.2020

5,000/‐ 115‐KP‐DD(MD) 24.02.2020

MARCH, 2020

56


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA

Manufacturing Site:

Boston Scientific Corporation, 780

Biliary Stent Introducer Biliary Device

Codes: M00533910 ‐8714729181439 7F (2.3mm) M00533920‐08714729193463 10F (3.3mm) Class : C

These devices are intended for use in the treatment of biliary strictures

3600‐A‐R&I

05.03.2020 50,000/‐ 116‐KP‐DD(MD)

05.03.2020

BROOKSIDE DRIVE SPENCER, IN USA, 47460 FSC FDA.U.S FOOD &DRUG Date of issue 26‐06‐2018 Valid till 25‐06‐2020

Shelf Life : 3 years

57


Legal Manufacturer:

M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 780 BROOKSIDE DRIVE SPENCER, IN USA, 47460 FSC F.D.A.U.S FOOD &DRUG Date of issue 26‐06‐2018 Valid till 25‐06‐2020

Products Name: C‐Flex Biliary Stent Codes: M00532010 08714729019077 7F (2.3mm) 5cm M00532020 08714729019084 7F (2.3mm) 10cm M00532030 08714729019091 7F (2.3mm) 15cm M00532040 08714729019107 10F (3.3mm) 5cm M00532050 08714729019114 10F (3.3mm) 10cm M00532060 08714729019121 10F (3.3mm) 15cm

Class : C Shelf Life : 3 years

These devices are intended for use in the treatment of biliary strictures

3600‐B‐R&I

05.03.2020 50,000/‐

117‐KP‐DD(MD) 05.03.2020

58


Legal Manufacturer: M/s. Boston Scientific Corporation, 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 780 BROOKSIDE DRIVE SPENCER, IN USA, 47460 FSC CFG 12311‐6‐2018

Date of issue 26‐06‐2018

Valid till 25‐06‐2020

EndoVive Standard PEG Kit

Enteral Feeding Kit Adult/Pediatric Codes: M00568401 08714729168904 20Fr, Push M00568411 08714729168911 24Fr, Push M00568381 08714729168881 20Fr, Pull M00568391 08714729168898 24Fr, Pull Class: C Shelf Life: 3 years

The Initial Placement Standard PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means

3600‐D‐R&I 05.03.2020

50,000/‐ 118‐KP‐DD(MD)

05.03.2020

59


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA

Manufacturing Site: Boston Scientific Corporation 2546 First Street, Propark El Coyol, Alajuela COSTA RICA 20904 FSC FDA.U.S FOOD&DRUG Date of issue 16‐04‐2019 Valid till 15‐04‐2021

Ultratome XL Triple Lumen Sphincterotome (Endoscopic electrosurgical electrode, monopolar single‐use) Codes: M00535900 ‐8714729103257 5mm Short Nose ‐ 20mm Cut Wire M00535910 08714729103301 20mm Long Wire‐ 20mm Cut Wire‐ M00535920 08714729103318 5mm Short Nose ‐ 30mm Cut Wire‐ M00535930 08714729103349 20mm Long

The device is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papila of Vater and/or the Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.

3600‐E‐R&I 05.03.2020

25,000/‐ 119‐KP‐DD(MD)

05.03.2020

60


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 2546 First Street, Propark El Coyol, Alajuela COSTA RICA 20904 FSC CFG 8156‐4‐2019 Date of issue 16‐04‐2019 Valid till 15‐04‐2021

Products Name: Hydra Jagwire Single‐Use High Performance Guidewire Codes: M00556001 08714729648437 0.035”/260cm/STD Shaft/STR Tip M00556011 08714729648444 0.035”/260cm/ STD Shaft/ANG Tip M00556021 08714729648451 0.035”/260cm/Stiff Shaft/STR Tip M00556031 08714729648468 0.035”/260cm/ Stiff Shaft /ANG Tip M00556041 08714729648475 0.035”/450cm/ STD Shaft /STR Tip M00556051 08714729648482 0.035”/450cm/ STD Shaft /ANG Tip M00556061 08714729648499 0.035”/450cm/ Stiff Shaft /STR Tip M00556071 08714729648505 0.035”/450cm/ Stiff Shaft /ANG Tip Class : B Shelf Life : 3 years

The Hydra Jagwire Guidewire is indicated for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during bronchoscopic procedures

3600‐F‐R&I 05.03.2020

25,000/‐ 120‐KP‐DD(MD)

05.03.2020

61



Resolution 360 Clip (Ligation CLip Metallic) Codes: M00521240 08714729875666 155cm/Box 1 M00521241 08714729875673 155cm/Box 10 M00521242 08714729875680 155cm/ Box 20 M00521243 08714729875697 155cm/ Box 40 M00521230 08714729875628 235cm/ Box 1 M00521231 08714729875635 235cm/ Box 10 M00521232 08714729875642 235cm/ Box 20 M00521233 08714729875659 235cm/ Box 40 Class : C Shelf Life : 3 years

The Resolution Clip Family of Devices is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: Mucosal/sub‐mucosal defects < 3 cm , Bleeding ulcers, Arteries < 2 mm, Polyps < 1.5 cm in diameter, Diverticula in the colon, Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a upplemental closure method of luminal perforations < 20 mm that can be treated conservatively

3600‐G‐R&I 05.03.2020

50,000/‐ 121‐KP‐(MD) 05.03.2020

62



Gold Probe Single‐Use Bipolar Electrohemostasis Catheter Codes: M00560070 08714729174691 7Fr x 300cm M00560071 08714729071013 7Fr x 300cm, Box 5 M00560100 08714729174684 10Fr x 300cm M00560101 08714729071020 10Fr x 300cm, Box 5 M00560220 08714729099574 7Fr x 350cm Class : B Shelf Life : 2 years

The Injection Gold Probe Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: Peptic Ulcers Dieulafoy Lesions Mallory‐Weiss Tears Bleeding Polyp Stalks Arteriovenous Malformations (AVMs) Angiomata The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

3600‐H‐R&I 05.03.2020

25,000/‐ 122‐KP‐DD(MD)

05.03.2020

63


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 2546 First Street, Propark El Coyol, Alajuela COSTA RICA 20904 FSC FDA.U.S Food & Drug Date of issue 16‐04‐2019 Valid till 15‐04‐2021

Products Name: TRUEtome 39 Cannulating Sphincterotome Codes: M00584190 08714729827658 20mm Cut Wire M00584120 08714729827771 30mm Cut Wire M00584191 08714729827788 20mm Cut Wire‐Box 10 M00584121 08714729827665 30mm Cut Wire‐Box 10 M00584192 08714729827764 20mm Cut Wire‐Box 20 M00584122 08714729827719 20mm Cut Wire‐Box 20 Class : B Shelf Life : 2 years

The TRUEtome Cannulating Sphincterotome is indicated for use in the selective cannulation of the common bile ducts (CBD) and the transendoscopic sphincterotomy of the Papilla or Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to inject contrast medium

3600‐I‐R&I 05.03.2020

25,000/‐ 123‐KP‐DD(MD)

05.03.2020

64


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation 780 Brookside Drive Spencer, IN USA 47460 FSC FDA. U.S Food & DRug Date of issue 03‐04‐2019 Valid till 02‐04‐2021

Products Name: Ureteral Catheter Open End Ureteral Catheter Codes: M0064002041 08714729342113 8 F (2.7 mm) X 70 cm M0064002031 08714729342106 7 F (2.3 mm) X 70 cm M0064002021 08714729342090 6 F (2.0 mm) 70 cm M0064002011 08714729342083 5 F (1.7 mm) X 70 cm M0064002001 08714729342076 4 F (1.3 mm) X 70 cm Class : B Shelf Life : 4 years

Ureteral Catheters are indicated for use for catheterization of the urinary tract during interoperative procedures, including but not limited to the following applications: • Ureteral occlusion for injection of contrast media • Delivery of irrigation fluids to the ureter • Drainage of fluids from the urinary tract • Access, advancement or exchange of ancillary devices including guidewires.

3600‐I‐R&I 05.03.2020

25,000/‐ 124‐KP‐DD(MD)

05.03.2020

65


Legal Manufacturer: M/s. Boston Scientific Corporation 300, Boston Scientific Way, Marlborough, MA 01752 USA Manufacturing Site: Boston Scientific Corporation, 2546 First Street, Propark El Coyol, Alajuela COSTA RICA 20904 FSC FDA. U.S Food & DRug Date of issue 16‐04‐2019 Valid till 15‐04‐2021

Products Name: Resolution Clip Device Codes: M00522600 08714729504764 155cm, Box 1 M00522601 08714729504771 155cm, Box 10 M00522602 08714729504788 155cm, Box 20 M00522610 08714729504795 235cm, Box 1 M00522611 08714729504801 235cm, Box 10 M00522612 08714729504818 235cm, Box 20 Class : C Shelf Life : 3 years

The Resolution Clip Family of Devices is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: Mucosal/sub‐mucosal defects < 3 cm , Bleeding ulcers, Arteries < 2 mm, Polyps < 1.5 cm in diameter, Diverticula in the colon, Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

3600‐J‐R&I 05.03.2020

50,000/‐ 125‐KP‐DD(MD)

05.03.2020

Documents

Form 7-A Data KPK (List 2) M0062601490 22 F (7.4 mm) X17cm M0062601480 20 F (6.7 mm) X 17 cm M0062601470 18 F (6.1 mm) X 17 cm M0062601520 26 F (8.8 mm) X 17 cm M0062601460 16 F (5