LIST OF ACKNOWLEDGEMENTS RECIEPT FOR APPLICATION … List of... · Eucalimus (Sirolimus eluting...

LIST OF ACKNOWLEDGEMENTS RECIEPT FOR APPLICATION REGARDING

PROVISIONAL REGISTRATION OF MEDICAL DEVICES FOR IMPORT

(AS PER S.R.O 167(I)/2017)

Errors, omissions and mistakes, if any, may be reported to the Division of MD&MC

S.# ACK. No. Issue Date Name of Importer Product Name Name of Manufacturer 1. 00001-MD 19-04-2017 M/s Pak Punjab Cardex

Medical System, Office

No.202-2nd

Floor, Eden

Heights Jail Road,

Lahore

“DESyne

Novolimus Eluting

Coronary Stent

System

Manufactured by:-

M/s VistaMed Limited, Ireland.

Legal manufacturer:

M/s. Elixir Medical Corporation-

California 94085, USA

2. 00002-MD 19-04-2017 M/s ACP Systems, 13 &

23 Naval Fleet Club,

Iqbal (S.J) Shaheed Road,

Karachi

Pro-Flow

Cardiovascular

Angiography

Catheter

Manufactured by :

M/s Medtronic Vascular, 37A Cherry

Hill Dr. Danvers, MA, USA

Owner Operator:- M/s Medtronic Inc. 710 Medtronic

Parkway, Minneapolis, MN USA .

3. 00003-MD 19-04-2017 M/s ACP Systems, 13 &



Karachi

Sprinter Legend

Over-The-Wire Manufactured by :

M/s Medtronic Ireland, Parkmore

Business Park West, Galway, Ireland.

Owner Operator:

M/s Medtronic Inc. 710 Medtronic

Parkway, Minneapolis, MN USA.

4. 00004-MD 20-04-2017 M/s Atco Pharma

International (Private)

Limited, B-18, S.I.T.E,

Karchi

CRE8 Amphilimus

Eluting Coronary

Stent”

M/s CID S.p.A Strada per Crescentino

sn, 13040 Saluggia (VC), Italy

5. 00005-MD 20-04-2017 M/s Atco Pharma



Karchi

Avantgarde Chrono

Carbostent



6. 00006-MD 20-04-2017 M/s Health Tec, 10-B,

Street-24, Valley Road,

Westridge-I, Rawalpindi

Pointer

Angiographic

Catheter

M/s Pendracare International B.V. Van

der Waalspark 22, 9351 VC Leek, The

Netherlands

7. 00007-MD 20-04-2017 M/s Pak Punjab Cardex

Medical System, Office

No.202-2nd

Floor, Eden

Heights Jail Road,

Lahore

DESolve ®

Novolimus TM

Eluting

Bioresorbable

Coronary Scaffold

System

M/s. Elixir Medical Corporation-870

Hermosa Drive, Sunnyvale, California

94085, USA

8. 00008-MD 20-04-2017 M/s ACP Systems, 13 &



Karachi

Launcher Guide

Catheter

Manufacturer:

M/s Medtronic Vascular, 37-A Cherry

Hill Dr Danvers, MA, USA, Owner

Operator:

M/s Medtronic Inc.710 Medtronic Pkwy,

Minneapolis, MN USA

9. 00009-MD 20-04-2017 M/s Intek Corporation,

Office # 30, First Floor,

Al-Amin Plaza, The

Tsunami Gold

Coronary Stent

M/s Terumo Corporation, 44-1, 2-

chome, Hatagaya, Shibuya-Ku, Tokyo

Mall, Rawalpindi System 151-0072, Japan

10. 00010-MD 21-04-2017 M/s Atco Pharma



Karchi

PRO HP PEGASO

PTCA BALLOON

CATHETER



11. 00011-MD 21-04-2017 M/s SLT (Saving Life

Technologies), House

No.126-H -Block, Model

Town, Lahore.

Eucalimus

(Sirolimus eluting

coronary stent

system)

M/s eucatech AG Rebgartenweg 27

79756 Weil Am Rhein, Germany.

12. 00012-MD 24-04-2017 M/s ACP Systems, 13 &



Karachi

EOPA ® Arterial

Canula Manufactured By :

M/s Medtronic Mexico S.de R.L. de CV,

Av. Paseo Cucapah 10510 El Lago

Tijuana, Baja California, Mexico C.P.

22210

Owner Operator:


Parkway, Minneapolis, MN USA

13. 00013-MD 24-04-2017 -do- Bio-Medicus ®

One Piece Femoral

Venous Cannula

-do-

14. 00014-MD 24-04-2017 -do- MC2X ® Three

Stage Venous

Cannula

-do-

15. 00015-MD 24-04-2017 -do- Antegrade

Perfusion Cannula

-do-

16. 00016-MD 24-04-2017 -do- MC2 ® Two stage

Venous Cannulae

-do-

17. 00017-MD 24-04-2017 -do- Bio-Medicus ®

Insertion Kit”

-do-

18. 00018-MD 24-04-2017 -do- Bio-Medicus ®

One Piece Femoral

Arterial Cannula

-do-

19. 00019-MD 24-04-2017 -do- DLP ® Pulmonary

Artery Vent

Cannula

-do-

20. 00020-MD 24-04-2017 -do- Retrograde

Perfusion Cannula

-do-

21. 00021-MD 24-04-2017 -do- DLP ® Vessel

Cannula

-do-

22. 00022-MD 24-04-2017 -do- DLP ® Intra

Cardiac Sump

-do-

23. 00023-MD 24-04-2017 -do- NC Euphora Rapid

Exchange Balloon

Dilatation Catheter

-do-

24. 00024-MD 24-04-2017 -do- Sherpa Active

Guide Catheter

-do-

25.

00025-MD 24-04-2017 M/s 4S International,

Suite # 205, 2nd

Floor Al-

Fiza Glass Tower, main

Rashid Minhas Road,

Block 10-A, Gulshan-e-

Iqbal, Karachi

PROLIM”

Sirolimus Eluting

Coronary Stent with

Delivery System

RX

M/s BALTON SP.ZO.O. NOWY

SWIAT 7/1400496, WARSZAWA –

Poland

26. 00026-MD 24-04-2017 -do- ALEX” Cobalt

Chromium

Sirolimus Eluting

Coronary Stent with

-do-

Delivery System,

Rapid Exchange

27.

00027-MD 24-04-2017 M/s Sakuf Trading, 2nd

Floor G-34 Phase – 1,

Commercial Area, DHA,

Lahore

Magic Catheter M/s BALT Extrusion 10 rue de la Croix

Vigneron, 95160 Montmorency, France

28. 00028-MD 24-04-2017 -do- Silk+mono

diameter

(Intracranial self-

expandable stent)

-do-

29. 00029-MD 24-04-2017 -do- Leo+ (Self

expandable stent)

-do-

30.

00030-MD 24-04-2017 -do- Eclipse Catheter -do-

31.

00031-MD 24-04-2017 -do- Fargo Catheter -do-

32.

00032-MD 24-04-2017 -do- Sonic Catheter -do-

33.

00033-MD 24-04-2017 -do- Gold Balloon

(Latex Balloon)

-do-

34.

00034-MD 24-04-2017 -do- Vasco+ Catheter -do-

35.

00035-MD 24-04-2017 M/s Atco Pharma


Limited, B-18, S.I.T.E

Karachi

Fluydo Pegaso M/s CID S.p.A Strada per Crescentino


36. 00036-MD 24-04-2017 M/s B Braun, The Forum,

Suite 216, Khayaban-e-

Jami, Clifton Block 9,

Karachi

Angiodyn Contrast

Saver Tubing

Manufactured By:

AESCULAP CHIFA Sp. z o.o. ul.

Tysiaclecia 14 64-300 Nowy Tomsyl

Poland.

Legal Manufacturer:

M/s B. Braun Melsungen AG Carl-

Braun-StraBe 1 34212 Melsungen

Germany

37. 00037-MD 24-04-2017 -do- Angiodyn Guide

Wire

-do-

38.

00038-MD 24-04-2017 -do- Angiodyn High

Pressure Tubing

-do-

39.

00039-MD 24-04-2017 -do- Intradyn PTCA F8

-do-

40.

00040-MD 24-04-2017 -do- Angiodyn Manifold

Kit Pakistan

-do-

41.

00041-MD 24-04-2017 -do- Intradyn Arterial

Puncture Needle

(Seldinger

-do-

42.

00042-MD 24-04-2017 -do- Angiodyn Manifold -do-

43.

00043-MD 24-04-2017 -do- Angiodyn Contrast

Saver Spike

-do-

44.

00044-MD 24-04-2017 -do- Intradyn Arterial

with J3 guide wire

-do-

45.

00045-MD 26-04-2017 M/s 4S International,

Suite # 205, 2nd

Floor Al-


Rashid Minhas Road,


Iqbal, Karachi.

Cobalt-Chromium

Coronary Stent

Coflexus”



Poland.

46. 00046-MD 26-04-2017 -do- Coronary

Angioplasty

Catheter Fryderyk

-do-

47. 00047-MD 28-04-2017 M/s Sakuf Trading, 2nd

Floor, G 34 Phase -1,


Lahore

SPI (Intravascular

Spirales)

M/s Balt Extrusion, 10 rue de la Croix


48. 00048-MD 28-04-2017 M/s ACP Systems, 13 &



Karachi

Marinr Diagnostic

Catheter

Manufactured by:

M/s Medtronic Mexico S.de R.L. de CV,


Tijuana, Baja California, Mexico.

Owner Operator:


Parkway, Minneapolis, MN USA.

49. 00049-MD 28-04-2017 -do- Soloist Diagnostic

Catheter

-do-

50.

00050-MD 28-04-2017 -do- RF Conductr

Ablation Catheters

-do-

51.

00051-MD 28-04-2017 -do- RF Marinr Ablation

Catheters

-do-

52.

00052-MD 28-04-2017 -do- Torqr Ablation

Catheters

-do-

53.

00053-MD 28-04-2017 -do- StableMapr

Diagnostic

Catheters

-do-

54.

00054-MD 28-04-2017 -do- RF Enhancer II

Ablation Catheters

-do-

55.

00055-MD 28-04-2017 M/s Verizon, 60-D,

F.C.C. Zahoor Elahi

Road, Gulberg-IV,

Lahore

Inoue-Balloon

Catheter

M/s Toray Industries, Inc., 1-1,

Nihonbashi-Muromachi 2-chome, Chou-

ku, Tokya, 103-8666, Japan

56. 00056-MD 28-04-2017 M/s Ferozsons

Laboratories Limited,

P.O Ferozsons,

Amangarh, Nowshera

Rubicon TM

18

Support Catheter

Manufactured by:

M/s Boston Scientific Corporation Two

Scimed Place Maple Grove, MN 55311

USA.

Legal manufacturer:

M/s Boston Scientific Corporation 300

Boston Scientific Way Marlborough MA

01752 USA.

57. 00057-MD 28-04-2017 -do- Rubicon TM

14

Support Catheter

-do-

58.

00058-MD 28-04-2017 -do- EpicTM

Over The

Wire Self-

Expanding Nitinol

Stent with Delivery

System

Manufactured by:


Nathan Lane Plymouth, MN 55442 USA

Legal manufacturer:



01752 USA.

59. 00059-MD 28-04-2017 -do- NC Emerge

Monorail PTCA

Dilatation Catheter

Manufactured by:

M/s Boston Scientific Corporation Two

Scimed Place Maple Grove, MN 55311

USA.

Legal manufacturer:



01752 USA.

60. 00060-MD 28-04-2017 -do- Rubicon TM

35

Support Catheter

-do-

61.

00061-MD 28-04-2017 -do- XXL Vascular

Balloon Dilatation

Catheter

Manufactured by:

M/s Boston Scientific Corporation

Ballybrit Business Park Galway, Ireland

Legal manufacturer:



01752 USA.

62. 00062-MD 28-04-2017 -do- WallgraftTM

Over

the Wire

Endoprosthesis

with UnistepTM

Plus

Delivery System

-do-

63.

00063-MD 28-04-2017 -do- Omega Monorail

PtCr Coronary

Stent System

-do-

64.

00064-MD 28-04-2017 -do- Wallstent-Uni TM

Endoprosthesis Self

Expanding Stent

Manufactured by:



Legal manufacturer:



01752 USA.

65. 00065-MD 28-04-2017 -do- Renegade Fiber

Braided

Microcatheter

Manufactured by:


Business and Technology Park Model

Farm Road Cork, Ireland

Legal manufacturer:



01752 USA.

66. 00066-MD 28-04-2017 -do- XXL Esophageal

Balloon Dilatation

Catheter

Manufactured by:



Legal manufacturer:



01752 USA.

67. 00067-MD 28-04-2017 M/s Maxims Medical,

210 2nd

Floor Land Mark

Plaza Jail Road Lahore

Stemi Cath

Thrombo-aspiration

Catheter

M/s Minvasys – 7, rue du Fosse Blanc-

92230 Gennevilliers France

68. 00068-MD 28-04-2017 -do- Yangtze µ PTCA

Balloons Catheter

-do-

69.

00069-MD 04-05-2017 -do- Yangtze NC PTCA

Balloons

-do-

70.

00070-MD 04-05-2017 M/s Cor-Med, 2nd

Floor,

38/62 Rehman Plaza

Bank Road, Saddar,

Rawalpindi

One Step TM

Centesis Catheter

Owner operator:

M/s Merit Medical Systems, Inc 1600

West Merit Parkway South Jordan UT

84095 USA.

Manufactured by:

M/s Merit Maquiladora Mexico, S. DE

R. L. DE C.V. Avenida Sor Juana Ines

de la Cruz 19970 Interior B, Edificio 2,

Parque Industrial Frontera Tijuana, Baja

California MEXICO 22630

71. 00071-MD 04-05-2017 -do- ASAP (Aspiration

Catheters

Owner operator/manufactured by: M/s

Merit Medical Systems, Inc 1600 West

Merit Parkway South Jordan UT 84095

USA

72. 00072-MD 04-05-2017 -do- Laureate TM

Merit

(Hydrophilic Guide

Wire

Owner operator:



84095 USA.

Manufacturing site:

M/s MERIT MEDICAL IRELAND,

LTD Parkmore Business Park West

Glaway, Galway IRELAND 0000

73. 00073-MD 04-05-2017 -do- MAK/Mini Access

Kits (Micro

Puncture Set

Owner operator:



84095 USA.

Manufactured by:

M/s Merit Maquiladora Mexico, S. DE

R.L. DE C.V. Avenida Sor Juana Ines de

la Cruz 19970 Interior B, Edificio 2 ,

Parque Industrial Frontera Tijuana, Baja

California MEXICO 22630

74. 00074-MD 04-05-2017 -do- Performa®

(Angiography

Catheters)

-do-

75.

00075-MD 04-05-2017 -do- EN Snare®

(Endovascular

Snare System)

Owner operator is M/s Merit Medical

Systems, Inc 1600 West Merit Parkway

South Jordan UT 84095 USA.

Manufactured site is M/s MERIT

MEDICAL IRELAND, LTD Parkmore

Business Park West Glaway, Galway

IRELAND 0000

76. 00076-MD 04-05-2017 -do- Bearing TM

nsPVA

(Embolization

Particles)”

Owner operator:



84095 USA.

Manufactured by:

M/s BIOSPHERE MEDICAL SA, Parc

des Nations – Paris Nord 2, 383 rue de la

Belle Etoile 95700 ROISSY EN

FRANCE FRA Roissy, Val-dOise

FRANCE 95700

77. 00077-MD 04-05-2017 -do- Basix Touch TM

(Inflation Device

Owner operator/manufactured by: M/s

Merit Medical Systems, Inc 1600 West

Merit Parkway South Jordan UT 84095

USA

78. 00078-MD 04-05-2017 -do- Prelude® Sheath

Introducers

-do-

79.

00079-MD 04-05-2017 -do- Concierge (Guiding

Catheters)

Owner operator:



84095 USA.

Manufactured by:

M/s Merit Medical Systems, Inc. 14646

Kirby Drive Houston, TX USA 77047

80. 00080-MD 04-05-2017 -do- ResolveTM

(RBC)

Billary Locking

Drainage Catheters

-do-

81.

00081-MD 04-05-2017 -do- Resolve TM

Locking

(RLC) Drainage

Catheters

-do-

82.

00082-MD 04-05-2017 -do- Impress

(Angiographic

Catheters)

-do-

83.

00083-MD 04-05-2017 -do- Merit Maestro TM

(Micro Catheters)

Manufactured by:



84095 USA.

84. 00084-MD 10-05-2017 M/s Tek Enterprises,

Office No. MZ9 Al-

Hafeez Heights 45-D Sir

Syed Road, Gulberg III,

Lahore

ASAHI Corsair

Microcatheter

Marketed by:

M/s ASAHI INTECC CO., LTD., 1730

Wakita-cho, Moriyama-ku, Nagoya, Aichi,

463-0024, JAPAN.

Manufacturing site:

M/s ASAHI Intecc Co., Ltd. Seto Factory 3-

100 Akatsuki-cho, Seto, Aichi 489-0071,

Japan

85. 00085-MD 10-05-2017 -do- ASAHI Hyperion

Coronary Guide

Catheter

-do-

86.

00086-MD 10-05-2017 -do- ASAHI PTCA

Guide Wire

-do-

87.

00087-MD 10-05-2017 M/s Anwar & Sons,

Apartment No.10, Safari

Villas -2, Commercial

Complex, Phase – 7,

Bahria Town Rawalpindi

Emosist® M/s Mascia Brunelli S.p.A, Viale Monza

272 – 20128 Milano Italy

88. 00088-MD 10-05-2017 -do- BONE WAX” M/s SMI AG Steinerberg 8 4780 St.

Vith Belgium

89. 00089-MD 10-05-2017 M/s Bio-Medics Medical

System, F-597, F-Block,

Satellite Town,

Rawalpindi

OSIRACR (Cobalt

Chromium

Rapamycin Eluting

Coronary Stent)

M/s Alco Advanced Lightweight

Constructions GmbH, Am Borsigturm

50, D-13507 Berlin Germany

90. 00090-MD 16-05-2017 M/s Alliance Medical,

12-B, 1st Floor, Agro

Flats, Shadman, Lahore

Central Venous

Catheters and

Catheterization Kit

M/s Biosensors International Pte. Ltd.

36 Jalan Tukang 619266 Singapore

91. 00091-MD 16-05-2017 -do- Biosensors

(Embolectomy)

Catheters

-do-

92.

00092-MD 16-05-2017 M/s Bio-Medics Medical

System, F-597, F-Block,

Satellite Town,

Rawalpindi

OSIRAAX-R

(Rapamycin Eluting

PTCA Catheter)”

M/s Alco Advanced Lightweight

Constructions GmbH, Am Borsigturm

50, D-13507 Berlin Germany

93. 00093-MD 16-05-2017 M/s A.H Distributors,

KH-1183 Lane No.5

Peshawar Road

Rawalpindi

Ursa Angiographic

Catheter

M/s Curatia Medical Ltd. 198

Xiangjiang Road new District Suzhou,

Jiangsu CHINA

94. 00094-MD 16-05-2017 -do- Accoat Guide

Wires

M/s SP Medical A/S Mollevej 1 DK-

4653 Karise, Denmark

95. 00095-MD 16-05-2017 M/s Health Care

International, Office No

1, 1st floor House No 42,

Street No 171 Shahbaz

Park Madina Colony

Baghbanpura, Lahore

Vesolock Surgical

Clips & Appliers

M/s Vesocclude Medical, LLC 7429

ACC Blvd, Suite 101 Raleigh, NC USA

27617

96. 00096-MD 16-05-2017 -do- Small, Narrow,

Medium, Large,

Wide, Titanium

Ligation Clips

-do-

97.

00097-MD 16-05-2017 M/s A & E Medical, 323

– Ata Turk Block New

Garden Town Lahore

Haemofilters M/s Allmed Medical GmbH

Mittelbacher Strabe 18 D-01896 Pulsnitz

Germany

98. 00098-MD 19-05-2017 M/s Sakuf Trading, 2nd

Floor, G 34 Phase -1,


Lahore

RYVA (Connection

Device)”

M/s BALT Extrusion 10 rue de la Croix


99. 00099-MD 19-05-2017 -do- “Baltacci

(Catheter)”

-do-

100.

00100-MD 19-05-2017 -do- “Introducer with

Valve”

-do-

101.

00101-MD 19-05-2017 -do- “Cirrus (Flow

Coils)”

-do-

102.

00102-MD 22-05-2017 M/s Maxims Medical,

210 2nd

Floor Land Mark

Plaza Jail Road Lahore

“Amazonia Sir

Drug Eluting

Coronary Stent”

M/s Minvasys 7, rue du Fosse Blanc,

Batiment C1, 92230 Gennevilliers,

France

103. 00103-MD 22-05-2017 M/s A & E Medical, 323


Garden Town Lahore

BEO NC PTCA

Balloon Catheters

M/s SIS Medical AG, Hungerbuelstrasse

12a, 8500 Frauenfeld, Switzerland and

Distributed by: M/s SIS Medical

Distribution AG, Hungerbuelstrasse 12a,

8500 Frauenfeld, Switzerland

104. 00104-MD 22-05-2017 -do- OPN NC PTCA

Balloon Catheters

-do-

105.

00105-MD 22-05-2017 -do- NIC 1.1 PTCA

Balloon Catheters

-do-

106.

00106-MD 22-05-2017 -do- TIN PTCA Balloon

Catheters

-do-

107.

00107-MD 22-05-2017 -do- NIC Nano PTCA

Balloon Catheters

-do-

108. 00108-MD 25-05-2017 M/s A.H Distributors,

KH-1183 Lane No.5

Peshawar Road

Rawalpindi

MSM CIS CoCr

(Balloon

Expandable

Coronary Cobalt

Chromium Stent

System)

M/s Meisebweg 5, D-75443 Oetishiem,

Germany.

109. 00109-MD 25-05-2017 -do- MSM PTCA

Balloon Catheter

(Semi-compliant

PTCA balloon

catheter)

-do-

110.

00110-MD 25-05-2017 -do- MSM DES

Sirolimus (Balloon

Expandable

Coronary Drug

Eluting Stent

System)

-do-

111.

00111-MD 25-05-2017 -do- Champion TM

PTCA Guide Wires

M/s SP Medical A/S, Mollevej 1 DK-

4653 Karise, Denmark

112. 00112-MD 25-05-2017 M/s 4S International,

Suite # 205, 2nd

Floor Al-


Rashid Minhas Road,


Iqbal, Karachi

Introducer version

braided or non-

braided kits to

introduce and

exchange

catheters and

endocavitary

electrodes, with

hemostasis valve



Poland

113. 00113-MD 25-05-2017 M/s Verizon, 60-D

F.C.C. Zahoor Elahi

Road, Gulberg IV,

Lahore

Aortic Expanded

Hemodynamic Plus

(St. Jude Medical®

Mechanical Heart

Valve- SJM®

Masters Series-

Rotatable)

Manufactured by: M/s St. Jude

Medical, Puerto Rico, LLC LOT 20-B

St. Caguas, PR USA 00725.

Legal manufacturer: M/s St. Jude

Medical 177 County Road B E Saint

Paul, MN USA 55117

114. 00114-MD 25-05-2017 -do- Mitral Expanded

(St. Jude Medical®

Mechanical Heart

Valve- SJM®

Masters Series-

-do-

Rotatable)

115.

00115-MD 25-05-2017 -do- SJM® Masters

Series Coated

Aortic Valved Graft

(alt.collagen

source)

-do-

116.

00116-MD 25-05-2017 -do- SJM® TailorTM

Annuloplasty ring

-do-

117.

00117-MD 26-05-2017 M/s Health Tec, 10-B,

Street-24, Valley Road,

Westridge-I, Rawalpindi

Xlimus Sirolimus

Eluting Stent

M/s Cardionovum Spolka z organixzona

odpowiedzialnoscia ul. Panska 73,00-

834 Warszawa Poland

118.

00118-MD 26-05-2017 M/s Mediland Pakistan

(Pvt) Ltd, Office # B-09,

2nd

Floor, Masood

Arcade, IJP Road Near

Saidpur Road,

Rawalpindi

Linear Intra Aortic

Balloon Catheter.

M/s Datascope Corp. 15 Law Dr

Fairfield, NJ, USA 07004

119. 00119-MD 26-05-2017 M/s A & E Medical, 323


Garden Town Lahore

NAMIC

Angiographic

Manifold”

Manufactured by M/s Navilyst Medical,

Inc., an AngioDyamics Company 10

Glens Falls Technical Park Glens Falls,

NY USA 12801.

Legal Manufacturer: M/s Navilyst

Medical, Inc., an AngioDynamics

Company 26 Forest St. Marlboro, MA

USA 01752

120. 00120-MD 26-05-2017 -do- NAMIC

Angiographic

Control Syringe

-do-

121.

00121-MD 26-05-2017 M/s Digital Imaging

Systems, 121 Habitat

Apartments, Shadman II,

Ghaus-ul-Azam Road,

Lahore

Hi-Torque

Powerturn Guide

Wires

M/s Abbott Vascular, 3200 Lakeside Dr

Santa Clara, CA USA 95054

122. 00122-MD 26-05-2017 -do- Hi-Torque Pilot

Guide Wires with

Hydrophilic

Coating


Santa Clara, CA USA 95054

Manufacturing sites:

(i) M/s Abbott Vascular Cashel Road

Clonmel. Tipperary Ireland.

(ii) M/s Abbott Vascular 26531 Ynez

Rd. Temecula, CA USA 92591.

(iii) M/s Abbott Vascular Costa Rica

52 Calle 3, B31 Coyol Free Zone

El Coyol, Alajuela Costa Rica.

(iv) M/s Abbott Vascular Road # 2, km

58.0, Cruce Davila Barceloneta,

PR USA.

123. 00123-MD 31-05-2017 M/s Genus, 220, Block-3,

S. Abdul Tawwab Road,

DMCHS, Karachi

C-LineTM

(Central

Venous Catheter

Kit)

M/s Umbra Medical Products, Inc., 8930

E Roan Ln Inverness, FL USA 34450

124. 00124-MD 31-05-2017 M/s Digital Imaging



Ghaus-ul-Azam Road,

Lahore

Priority Pack with

Copilot Bleedback

Control Valve”


Santa Clara, CA USA 95054 and

Contract Manufacturer:

M/s Availmed S.A. DE C.V. (Mexico)

Ave. Paseo Reforma No. 8950 Interior

(C1, E1, E2, F2, G1 (Local A,B,C,G,H))

La Mesa TIJUANA, Baja California

Mexico

125. 00125-MD 09-06-2017 M/s A & E Medical, 323


Garden Town Lahore

Pressure Lines M/s Sunny Medical Device (Shenzhen)

Co., Ltd. 4/F and 5/F Dongpingxing,

Creative Science Park Longgang District

Shenzhen, Guangdong China, 518172




Ghaus-ul-Azam Road,

Lahore

Hi-Torque Whisper

Guide Wire with

Hydrophilic

Coating


Santa Clara, CA USA 95054 Manufacturing

sites:

(i) M/s Abbott Vascular Cashel Road

Clonmel. Tipperary Ireland.

(ii) M/s Abbott Vascular 26531 Ynez Rd.

Temecula, CA USA 92591.

(iii) M/s Abbott Vascular Costa Rica 52

Calle 3, B31 Coyol Free Zone El

Coyol, Alajuela Costa Rica.

(iv) M/s Abbott Vascular Road # 2, km

58.0, Cruce Davila Barceloneta, PR

USA.

127. 00127-MD 09-06-2017 Hi-Torque Balance

Guide Wire with

Hydrocoat

Hydrophilic

Coating

-do-

128.

00128-MD 09-06-2017 Hi-Torque Cross IT

Guide Wire with

Hydrocoat

Hydrophilic

Coating

-do-

129. 00129-MD 09-06-2017 M/s Cardiac Care, 848-

C, Shadman – I, Lahore

Everest Titanium

Ligating Clip”

(Hemostatic Titanium

Ligating Clip)

M/s MDD Medical Device Development

GmbH Steigacker 20 (industrial Area)

D-78582 Balgheim, Germany

130. 00130-MD 14-06-2017 M/s Medisurg

Innovatives Health

Care, 1/6-N, Block – 6,

PECHS Nursery, Main

Shahrah e Faisal

Karachi

General Purpose

Drainage Catheter

M/s Uresil, LLC 5418 West Touhy Ave.

Skokie, IL USA 60077

131. 00131-MD 14-06-2017 -do- ALN Optional Vena

Cava Filter

Manufactured by/the authorized

representative: M/s A.L.N. Route de la

Gare 20240 Ghisonaccia France

Production site: M/s A.L.N. 589 Chmin

du Niel 83230 Bormes Les Mimosas

France

132. 00132-MD 14-06-2017 -do- Passeo-14 Peripheral

Dilatation Cather

M/s Biotronik AG, Ackerstrasse 6, 8180

Bulach, Switzerland.

133. 00133-MD 14-06-2017 -do- Dynamic Renal –

Renal Stent System

-do-

134.

00134-MD 14-06-2017 -do- Dynamic Peripheral

Stent and Delivery

System

-do-

135.

00135-MD 14-06-2017 -do- Pulsar–18 Peripheral

Self-Expanding

Nitinol Stent System

-do-

136.

00136-MD 14-06-2017 -do- Passeo–18 Lux

Paclitaxel releasing

PTA Balloon

Catheter

-do-

137.

00137-MD 14-06-2017 -do- Pantera LUX

Paclitaxel Releasing

PTCA Balloon

Catheter

-do-

138.

00138-MD 14-06-2017 -do- Nephroureteral Stent

Catheter



139. 00139-MD 14-06-2017 -do- Orsiro Sirolimus

Eluting Coronary

Stent System

M/s Biotronik AG, Ackerstrasse 6, 8180

Bulach, Switzerland.

140. 00140-MD 14-06-2017 -do- PK Papyrus Covered

Coronary Stent

System

-do-

141.

00141-MD 14-06-2017 -do- Pantera Pro Coronary

Dilatation Catheter

-do-

142.

00142-MD 14-06-2017 -do- Pantera LEO Fast-

Exchange PTCA

Catheter

-do-

143.

00143-MD 14-06-2017 -do- PRO-Kinetic Energy

Coronary Stent

System

-do-

144.

00144-MD 14-06-2017 -do- Chole-Cath (CC-

Biliary Drainage

Catheter)



145. 00145-MD 14-06-2017 -do- Nephro-Cath

(Nephrostomy

Drainage Catheter

-do-

146.

00146-MD 14-06-2017 -do- Mini Drainage

Catheter

-do-

147.

00147-MD 16-06-2017 M/s Cardiac Care, 848-


Leadercath (Arterial

Catheter)

M/s Vygon – 5 rue Adeline – 95440

Ecouen – France

148. 00148-MD 16-06-2017 -do- Memo 3D

(Annuloplasty Ring)

M/s Sorin Group Italia S.r.l., (Liva

Nova) Via Benigno Crespi 17, 20159

Milano, Itlay

149. 00149-MD 16-06-2017 -do- Carbomedics Carbo-

seal (Aortovalvular

prosthesis)

-do-

150.

00150-MD 20-06-2017 M/s Flowtronix System,

Flat No.02, 1st Floor

Al-Ashraf Plaza Range

Road, Rawalpindi

Two Stage Venous

Catheter (Andocor)”

M/s Andocor NV – Kwikaard 104 –

2980 Zoersel – Belgium

151. 001151-MD 20-06-2017 -do- Arterial Cannulae

Reinforced

(Andocor)

-do-

152.

00152-MD 20-06-2017 -do- Flex Line Venous

Catheter (Andocor)”

-do-

153.

00153-MD 20-06-2017 -do- Pericardial Sump

(Andocor)

-do-

154.



Sterile Silgle use

Epicardial Electrodes

Myopace, Unipolar

M/s FIAB S.p.A., Via P. Costoli 4,

50039 Vicchio (FI) Italy

155. 00155-MD 03-07-2017 -do- Prolongateur

Lectrocath /

Lectrocath Extension

Line


Ecouen – France

156. 00156-MD 03-07-2017 -do- Dideco D901 Lilliput

(Infant – Newborn

Oxygenators)

M/s Sorin Group Italia S.r.l., Via

Benigno Crespi 17, 20159 Milano (MI)

Italy

157. 00157-MD 03-07-2017 -do- Ultra IABP 7 FR

Catheter Kit

M/s Insightra Medical Inc, 9891 Irvine

Center DR STE 222 Irvine, CA USA

92618

Contract Manufacturer:

M/s Life Science Outsourcing, Inc, 830

Challenger Street Brea, CA USA 92821

158. 00158-MD 03-07-2017 -do- Inspire (Adult and

Small Oxygenators)



Italy




Temporary

Myocardial

Stimulation Electrode

M/s Osypka AG Earl-H. – Wood –

Strabe 1, Rheinfelden 79618, Germany

160. 00160-MD 03-07-2017 -do- Percutaneous

Valvuloplasty

Balloon Catheter

-do-

161.

00161-MD 03-07-2017 M/s Intek Corporation,

No.30, ISt Floor Al-

Amin Plaza, The Mall

Rawalpindi

Thrombuster II M/s Kaneka Medix Corporation

Kanagawa Plant 225-1, Aza Deguchi,

Yamakita, Yamakita-machi, Ashigara-

Kami-gun, Kanagawa, 258-0113 JAPAN

162. 00162-MD 03-07-2017 M/s Cardiovascular

Medical System

(CMS), Office No 210-

J-11, M.A Johar Town

Lahore

ISTAR PTCA

Balloon Catheter

M/s amg International GmbH, Boschstr.

16, D-21423 Winsen Germany

163. 00163-MD 03-07-2017 -do- ISOLV Aspiration

Catheter

-do-

164.

00164-MD 04-07-2017 M/s Global Marketing

Services 111,Hali Road

Westridge 1,

Rawalpindi

INFINITI ®

Diagnostic Catheter

Legal Manufacturer: M/s Cordis

Corporation, 14201 N,W.60th Avenue.

Miami lakes, FL USA 33014.

Manufacturing Site:-

M/s CORDIS DE MEXICO, S.A.DE

C.V.Calle Circuito Interior Norte

No.1820 Parque Industrial Salvarcar,

Ciudad Juarez, Chihuahua, Mexico, CP

32574.

165. 00165-MD 04-07-2017 -do- SUPER TORQUE ®

Plus Angiographic

Catheter

-do-

166.

00166-MD 04-07-2017 -do- SUPER TORQUE ®

Angiographic

Catheter

-do-

167.

00167-MD 04-07-2017 -do- TEMPO ®

Angiographic

Catheter

-do-

168.

00168-MD 04-07-2017 -do- TEMPO ® Aqua ®

Angiographic

Catheter

-do-

169.

00169-MD 04-07-2017 -do- HIGH FLOW

Angiographic

Catheter

-do-

170.

00170-MD 04-07-2017 -do- VISTA BRITE TIP

® Guiding Catheter.

-do-

171.

00171-MD 04-07-2017 -do- BRITE TIP ® Sheath

Introducer.

-do-

172.

00172-MD 04-07-2017 -do- AVANTI ® +

Introducer

-do-

173.

00173-MD 04-07-2017 -do- ADROIT Guiding

Catheter

-do-

174.

00174-MD 04-07-2017 -do- SABER TM

PTA

Balloon Dilatation

Catheter

Legal Manufacturer:

M/s Cordis Cashel, Cahir Road, Cashel

Co., Tipperary, Ireland.


M/s CORDIS DE MEXICO, S.A.DE

C.V.Calle Circuito Interior Norte

No.1820 Parque Industrial Salvarcar,

Ciudad Juarez, Chihuahua, Mexico, CP

32574.

175. 00175-MD 04-07-2017 -do- Maxi LD PTA

Dilatation Catheter

-do-

176.

00176-MD 04-07-2017 -do- Powerflex ® Pro

PTA Dilatation

Catheter

M/s Cordis Corporation 14201,N.W.60th

Ave. Miami Lakes. FL USA 33014

Manufacturing site:

M/s Cordis De Mexico S.A. DE C.V.

Calle Circuito Interior Norte # 1820

Parque Industrial Salvarcar Ciudad

Juarez, Chihuahua Mexico CP 32574

177. 00177-MD 04-07-2017 -do- EMPIRA NC RX

PTCA Dilatation

Catheter

Legal Manufacturer:

M/s Cordis Corporation, 14201

N,W.60th Avenue. Miami lakes, FL

USA 33014.


M/s Creganna Medical also d/b/a

Cregganna Tactx Medical 1353 Dell

Avenue, Campbell, CA95008, USA

178. 00178-MD 04-07-2017 -do- TrapEase Permanent

Vena Cava Filter and

Introduction.

Legal manufactureR:

M/s Cordis Cashel, Cahir Road, Cashel,

Co. Tipperary Ireland having

Manufacturing site:

M/s Cordis De Mexico S.A. DE C.V.

Calle Circuito Interior Norte # 1820

Parque Industrial Salvarcar Ciudad

Juarez, Chihuahua Mexico CP 32574

179. 00179-MD 04-07-2017 -do- Optease Retrievable

Vena Cava Filter and

Introduction Kit.

-do-

180.

00180-MD 04-07-2017 -do- Emerald Diagnostic

Guide Wires

Legal Manufacturer:



USA 33014.


M/s Lake Region Medical Limited, 340

Lake Hazeltine DR Chaska, MN USA

55318.

181. 00181-MD 04-07-2017 -do- ATW (Marker

Intermediate) Guide

Wires

-do-

182.

00182-MD 04-07-2017 -do- EMPIRA RX PTCA

Dilatation Catheter

Legal Manufacturer:



USA 33014.


M/s Creganna Medical also d/b/a

Cregganna Tactx Medical 1353 Dell

Avenue, Campbell, CA95008, USA

183. 00183-MD 04-07-2017 M/s Hashir Surgical

Services, Office # 16,

Street 1, Sector F-2,

Phase 6, Hayatabad,

CrCo Coronary Stent

System COROFIC®”

M/s MACRIMASA-PHARMA

LABORATORIES S.A.

HEADQUARTERS Technological Park

of Andalusia. Marie Curie St, 3 29590

Peshawar Campanillas – Malaga – Spain

184. 00184-MD 04-07-2017 -do- Sirolimus Eluting

Coronary Stent

System COROFIC ®

-do-

185.

00185-MD 04-07-2017 M/s Sakuf Trading, 2nd

Floor G-34 Phase – 1,

Commercial Area,

DHA, Lahore

Barricade Coil

System

M/s Blockade Medical LLC, 18

Technology Dr Ste 169 Irvine, CA USA

92618

186. 00186-MD 04-07-2017 M/s Healthline

Pharmaceutical Pvt Ltd,

Office No.402 Al-

Hafeez Heights,

Gulberg 3, Lahore

Celox Granules

(Haemostatic

Granules)”

M/s MedTrade Products Limited, Electra

House, Crewe Business Park, Crewe

Cheshire, United Kingdom

187. 00187-MD 04-07-2017 M/s Flowtronix System,

Flat No.02, 1st Floor

Al-Ashraf Plaza Range

Road, Rawalpindi

Cardioplegia Set

(Andocor)”

M/s Andocor NV – Kwikaard 104 –

2980 Zoersel – Belgium

188. 00188-MD 04-07-2017 -do- Retrograde

Cardioplegia Cannula

-do-

189.

00189-MD 04-07-2017 -do- Vent Catheter

(Andocor)

-do-

190.

00190-MD 04-07-2017 -do- Ostial Perfusion

Cannula (Andocor)

-do-

191.

00191-MD 04-07-2017 -do- Aortic Catheter

(Andocor)

-do-

192.

00192-MD 04-07-2017 -do- Aortic Root Canula

(ANDOCOR)

-do-

193.

00193-MD 04-07-2017 -do- Aortic Punch -do-

194.

00194-MD 11-07-2017 M/s Medisurg

Innovatives Health

Care, 1/6-N, Block – 6,

PECHS Nursery, Main

Shahrah e Faisal

Karachi

Disposable Needles

for Biopsy Gun

M/s Moller Medical GmbH

Wasserkuppenstrabe 29-31, 36403

Fulda, Germany

195. 00195-MD 11-07-2017 -do- Fine Needle Biopsy

-do-

196.

00196-MD 11-07-2017 -do- Coaxial Needle -do-

197.

00197-MD 11-07-2017 -do- Bone Biopsy Needle -do-

198.



Multicath 4 M/s Vygon Gmbh & Co.KG Prager

Ring 100 52070 Aachen, Germany

199.

00199-MD 11-07-2017 -do- Multistar 4+ -do-

200.

00200-MD 11-07-2017 M/s Hashir Surgical

Services, Office # 16,

Street 1, Sector F-2,

Phase 6, Hayatabad,

Peshawar

Suction Catheter with

Control Valve

M/s Hangzhou Jinlin Medical

Appliances Co., Ltd, No.9, 16th Ave.

Hangzhou Economic and Technological

Development Zone, Hangzhou, China.



Multicath (Multicath

3)


Ecouen, France

202. 00202-MD 19-07-2017 -do- DIDECO Perfusion

Tubing Systems

(Customized

Perfusion Tubing

Systems for Cardiac

Surgery)

M/s Sorin Group Italia S.r.l., Via Statale

12 Nord, 86 – 41037 Mirandola (MO)

Italy

203. 00203-MD 19-07-2017 -do- Perfusion Tubing

Systems (Customized

Perfusion Tubing

Systems for Cardiac

Surgery)

-do-

204.

00204-MD 19-07-2017 M/s Universal

Enterprises, 29/3 Co-

Operative Housing

Society, Stadium Road

Karachi

Capiox RX

(Oxygenator)

M/s Ashitaka Factory of Terumo

Corporation 150, Maimaigi-cho,

Fujinomiya City, Shizuoka Prefecture,

Japan.

Marketed by:


chome, Hatagaya, Shibuya-ku, Tokyo,

Japan

205. 00205-MD 19-07-2017 M/s Global Marketing

Services 111,Hali Road

Westridge 1,

Rawalpindi

SHINOBI® Plus

Steerable Guidewire

Legal manufacturer:

M/s Cordis Corporation 14201,N.W.60th

Ave. Miami Lakes. FL USA 33014.

Manufacturing sites:

M/s Lake Region Medical, 340 Lake

Hazeltine Dr Chaska, MN USA 55318

and M/s Lake Region Medical Limited,

Butlersland New Ross, Wexford Ireland

206. 00206-MD 19-07-2017 M/s Mediland Pakistan

(Pvt) Ltd, Office # B-

09, 2nd

Floor, Masood

Arcade, IJP Road, Near

Saidpur Road,

Rawalpindi

Quadrox–I

(Oxygenator)

M/s Maquet Cardiopulmonary GmbH

Kehler Str. 31, 76437 Rastatt, Germany

207. 00207-MD 25-07-2017 M/s Maxims Medical,

210 2nd

Floor Land

Mark Plaza Jail Road

Lahore

E Magic Plus (Drug

Eluting Stent

Delivery System)

M/s Eurocor GmbH Ln Den Dauen 6a,

53117 Bonn, Germany

208. 00208-MD 25-07-2017 -do- Dior Paclitaxel

Eluting PTCA

-do-

Balloon Catheter

209.

00209-MD 26-07-2017 M/s Cor-Med, 2nd

Floor, 38/62 Rehman

Plaza Bank Road,

Saddar, Rawalpindi

iht DEStiny BD

Abluminal/Sirolimus

Eluting Coronary

Stent System

M/s IHT (Iberhospitex, S.A.) Avda

Catalunya 4- 08185 LLica de vall –

Barcelona Spain

210. 00210-MD 26-07-2017 -do- Crossway®

PTCA

Semicomplaint

Balloon

-do-

211.

00211-MD 26-07-2017 -do- Crossway NC®

PTCA Dilatation

Catheter

-do-

212.

00212-MD 26-07-2017 M/s S.J Traders, Flat

No. 5, 3rd

Floor, Plaza

75 Square, Commercial

Phase – 7, Bahria

Town, Rawalpindi

Spike Ultra LC

(Electrocatheters for

Temporary

Endocardial Pacing

and

Electrophysiological

Studies)


50039 Vicchio (FI), Italy

213. 00213-MD 26-07-2017 -do- Spike Easy LC R

(Electrocatheters for

Temporary

Endocardial Pacing

and


Studies)

-do-

214.

00214-MD 26-07-2017 M/s ACP Systems, 13

& 23 Naval Fleet Club,

Iqbal (S.J) Shaheed

Road, Karachi

Duran AnCore TM

Annuloplasty Ring

620R

Manufactured by:

M/s Medtronic Heart Valves Division

1851 East Deere Ave. Santa Ana, CA

USA 92705

M/s Medtronic Mexico S. de R. L. de

CV Av. Paseo Cucapah 10510 El Lago

Tijuana, Baja California Mexico C.P.

22210

Owner Operator:


Pkwy. Minneapolis, MN USA 55432

215. 00215-MD 26-07-2017 -do- CG Future TM

Annuloplasty Ring,

638R

-do-

216.

00216-MD 26-07-2017 -do- Simplici – T TM

Annuloplasty

System, 670

(670100)

-do-

217.

00217-MD 26-07-2017 -do- Profile 3D TM

Annuloplasty Ring,

680R

-do-

218.

00218-MD 26-07-2017 -do- Contour 3D TM

Annuloplasty Ring,

690R

-do-

219.

00219-MD 26-07-2017 M/s Mars Enterprises,

Office No. 4, Jason

Centre, 2nd

Floor, BC –

8, Block No.9, Clifton,

Karachi

Suction Catheter for

Single Use (i care)

M/s Yiles Medical Co., Ltd. Chuangye

Road 1199, Jinxian, Nanchang City,

331700 Jiangxi, China.

220. 00220-MD 26-07-2017 M/s Ferozsons

Laboratories Limited,

P.O Ferozsons,

Amangarh, Nowshera

Encore TM

26

Advantage Kit

Inflation Device Kit

Legal manufacturer:

M/s Boston Scientific Corporation, 300

Boston Scientific Way, Marlborough

Massachusetts 01752, USA.

Manufacturing site:

M/s Boston Scientific Limited, Business

and Technology Park, Model Farm

Road, Cork, Ireland

221. 00221-MD 26-07-2017 -do- Contour TM

Embolization

Particles

-do-

222.

00222-MD 26-07-2017 -do- ChoiceTM

PT Magnet

Guidewire with

ICETM

Hydrophilic

Coating

Legal manufacturer:


Boston Scientific Way, Marlborough

Massachusetts 01752, USA.

Manufacturing site:


Parkway, Global Park, Heredia, La

Aurora, Costa Rica

223. 00223-MD 26-07-2017 -do- PT GraphixTM

Guidewire with

-do-

ICETM

Hydrophilic

Coating

224.

00224-MD 26-07-2017 -do- Choice TM

Magnet

Guidewire with

ICETM

Hydrophilic

Coating

-do-

225.

00225-MD 26-07-2017 -do- Choice TM

PT

Guidewire with ICE TM

Hydrophilic

Coating

-do-

226.

00226-MD 26-07-2017 -do- V – 18 TM

Control

Wire TM

Guidewire

with ICE TM

Hydrophilic Coating

-do-

227.

00227-MD 26-07-2017 -do- V – 14 TM

Control

Wire TM

Guidewire

with ICE TM

Hydrophilic Coating

228. 00228-MD 26-07-2017 -do- Choice TM

Guidewire

with ICE TM

Hydrophilic Coating

-do-

229.

00229-MD 26-07-2017 -do- PT2 TM

Guidewire

-do-

230.

00230-MD 03-08-2017 M/s Mars Enterprises,

Office No. 4, Jason

Centre, 2nd

Floor, BC –

8, Block No.9, Clifton,

Karachi – 75600

Closed Suction

Catheter for Single

Use (i care)

M/s Yiles Medical Co., Ltd. Chuangye

Road 1199, Jinxian, Nanchang City,

331700 Jiangxi, China

231. 00231-MD 03-08-2017 M/s A & E Medical,

323 – Ata Turk Block

New Garden Town

Lahore

External Cardiac

Stimulator

“Easypace” and

Provided Related

Accessories


50039 Vicchio (FI) Italy

232. 00232-MD 03-08-2017 -do- Electrocatheters for

Temporary

Endocardial Pacing

and


Studies Spike LC S -

2 Poles

-do-

233. 00233-MD 08-08-2017 M/s Muller & Phipps

(Pvt.) Ltd , Plot No.

208, & 208/1, Sector

No. 23, Korangi

Industrial Area, Karachi

Bone Wax Legal manufacturer:

M/s Ethicon, LLC 475 C Street Los

Frailes Industrial Park, Suite 401

Guaynabo, PR USA 00969.

Manufacturing site :

M/s Johnson and Johnson do Brasil Ind.

Com. De Prod. p/Saude Ltda, Rodovia

Presidente Dutra KM 154 Sao Jose Dos

Campos, Sao Paulo Brazil 12240-908

234. 00234-MD 08-08-2017 M/s Sapphire

International, Room

No. 903, 9th

Floor Uni –

Centre I.I. Chundrigar

Road, Karachi

Mistral NC (PTCA

Balloon Catheter

Manufactured by:

M/s Hexacath, 4, Passage Saint

Antoine, 92500 Rueil Mamaison,

France.

Production site:

M/s Hexacath Maroc, 17 route 1029 –

Sidi Maarouf – Parc Tawfik Casablanca,

Morocco.



208, & 208/1, Sector

No. 23, Korangi


TFE Polymer

Pledgets

Legal manufacturer:

M/s Ethicon, LLC 475 C Street Los

Frailes Industrial Park, Suite 401

Guaynabo, PR USA 00969.

Manufacturing site:

M/s Ethicon, Inc. Calle Durango No.

2751 Lote Bravo Ciudad Juarez,

Chihuahua Mexico C.P. 32575

236. 00236-MD 10-08-2017 -do- Temporary Cardiac

Pacing Wire

(w/Wave)

Legal manufacturer/

manufacturing site:

M/s Ethicon, LLC. Highway 183 Km.

8.3 San Lorenzo, PR USA 00754

237. 00237-MD 10-08-2017 M/s ACP Systems, 13


Iqbal (S.I) Shaheed

Road, Karachi

DLP ® Single Stage

Venous Cannulae

Manufactured by:

M/s Medtronic Perfusion Systems 7611

Northland Dr Minneapolis, MN USA

55428.

Owner operator of the product:



Manufacturing facility:

M/s Medtronic Mexico S. de R.L. de CV



22210

238. 00238-MD 10-08-2017 -do- Simulus TM

Semi-

Rigid Annuloplasty

Ring, Model 800SR

Manufactured by:

M/s Medtronic Heart Valves Division

1851 East Deere Ave. Santa Ana, CA

USA 92705

M/s Medtronic Mexico S. de R. L. de

CV Av. Paseo Cucapah 10510 El Lago


22210.




239. 00239-MD 10-08-2017 -do- Medtronic Open

Pivot TM

Heart Valve,

Model 500FA

(Standard, Aortic)

Manufactured by :

M/s Medtronic, Inc. (Minneapolis, MN

55447), 3800 Annapolis Lane

Minneapolis, MN USA 55447.




240. 00240-MD 15-08-2017 -do- Sensia-SR (Model

SESR 01)

Legal manufacturer:

M/s Medtronic Inc.710 Medtronic

Parkway. Minneapolis, MN USA 55432.

Manufacturing site:

M/s Medtronic Singapore Operations

Pte. Ltd. 49 Changi South Avenue 2,

Nasaco Tech Centre, Singapore 486056,

Singapore

241. 00241-MD 15-08-2017 M/s Sapphire

International, Room

No. 903, 9th

Floor Uni –

Centre I.I. Chundrigar

Road, Karachi

Mistral SC (PTCA

Balloon Catheter)

Manufactured by:

M/s Hexacath, 4, Passage Saint Antoine,

92500 Rueil Malmaison, France.

Production site:

M/s Hexacath Maroc, 17 route 1029 –

Sidi Maarouf – Parc Tawfik Casablanca,

Morocco

242. 00242-MD 15-08-2017 M/s Universal


Operative Housing


Karachi

Tubing Set with X-

Coating (Optional)

pre-connected to

Hemoconcentrator

Manufactured by:

M/s Terumo Europe N.V.

Interleuvenlaan 40, 3001 Leuven,

Belgium



Al-Amin Plaza, The

Mall, Rawalpindi

Scoreflex PTA

Balloon Dilatation

Catheter (Coiled – 18

Series)

Manufactured by:

M/s OrbusNeich Medical B.V. Drs. W.

van Royenstraat 5, 3871AN Hoevelaken

The Netherlands

244. 00244-MD 16-08-2017 -do- JADE PTA Balloon

Dilatation Catheter

-do-

245. 00245-MD 16-08-2017 -do- Figulla ® Flex II

PFO (Occluder)

Manufactured by:

M/s Occlutech GmbH

Wildenbruchstrasse 15 07745 Jena

Germany.

Packaged/Distributed by:

M/s Occlutech International AB La

Cours Gata 2 25231 Helsingborg

Sweden 246. 00246-MD 16-08-2017 -do- Figulla ® Flex II

ASD (Occluder)

-do-

247. 00247-MD 16-08-2017 -do- Occlutech® Muscular

VSD Occluder

Manufactured by:

M/s Occlutech Tibbi Urunler San. Ve

Tic Ltd. Sti. AHL Serbest Bolgesi, E-5

Blok 34149 Barkirkoy/Istanbul Turkey.




Sweden



Al-Amin Plaza, The

Mall, Rawalpindi

Occlutech® PLD

Occluder

Manufactured by:







Sweden

249. 00249-MD 16-08-2017 -do- Crusade (Dual

Lumen Catheter)

Marketed by:

M/s Kaneka Corporation, 3-18, 2-

Chome, Nakanoshima, Kita-ku, Osaka-

city, Osaka, 530-8288, Japan

Manufacturing site:

M/s Kaneka Medix Corporation

Kanagawa Plant 225-1, Aza Deguchi,

Yamakita, Yamakita-machi, Ashigara –

Kami-gun, Kanagawa, 258-0113 Japan

250. 00250-MD 16-08-2017 -do- Occlutech® PDA

Occluder

Manufactured by:







Sweden



Multicath (Multicath

2)


Ecouen – France

252. 00252-MD 17-08-2017 -do- Dideco D902 Lilliput

2 (Infant Newborn

Oxygenators)



Italy

253. 00253-MD 17-08-2017 -do- Coronary Sinus

Cannulae (with self –

inflating PVC

Balloon)

M/s Sorin Group USA, Inc. 14401 West

65th

Way Arvada, Co USA 80004

254. 00254-MD 17-08-2017 -do- MYO Punch M/s Alto Development Corp. (DBA

A&E Medical Corp.) 5206 Asbury Road

P.O. Box 758 Farmingdale, NJ 07727

USA




PTCA Balloon

Catheter Clever

(Semi – Compliant)

M/s Conic Vascular Technology SA,

Via Carlo Maderno 23, CH-6901

Lugano, Switzerland

256. 00256-MD 17-08-2017 -do- PTCA Balloon

Catheter NC Clever

(Non-Compliant)

-do-

257. 00257-MD 18-08-2017 M/s ACP Systems, 13


Iqbal (S.I) Shaheed

Road, Karachi

Medtronic Open

Pivot TM

Heart Valve,

Model 500DM

(Standard, Mitral)

Manufactured by:-



Minneapolis, MN USA 55447 and




258. 00258-MD 18-08-2017 -do- Relia (Single

Chamber VVIR

Permanent

Pacemaker Model

Manufacturer:


Parkway. Minneapolis, MN USA 55432

Manufacturing site:


RESR01) Pte. Ltd. 49 Changi South Avenue 2,


Singapore

259. 00259-MD 18-08-2017 -do- Relia (DR Dual

Chamber Permanent

Pacemaker Model

REDR01)

Legal manufacturer:



Manufacturing site:




Singapore

260. 00260-MD 18-08-2017 -do- Relia (Single

Chamber VVI

Permanent

Pacemaker Model

RES01)

-do-



Apartments, Shadman

II, Ghaus-ul-Azam

Road, Lahore

Verrata Pressure

Guide Wire

Legal manufacturer:

M/s Volcano Corporation 2870 Kilgore

Rd. Rancho Cordova, CA USA 95670

Manufacturing site:

M/s Volcano Corporation by Volcarica

S.R.L.Coyol Free Zone and Business

Park Building B37 Coyol, Alajuela

Costa Rica None

262. 00262-MD 28-08-2017 M/s Advance

Cardiology System, 12,

Al-Sehat Centre,

Rafique H.J. Shaheed

Road, Hotel Regent

Plaza, Karachi

Artimes Balloon

Dilatation Catheter

Manufactured by:

M/s BrosMed Medical Co., Ltd. 15th

Building, SMES Venture Park,

Songshan Lake Hi Tech Industrial Dev.

Zone Dongguan, Guangdong 523808

China

263. 00263-MD 28-08-2017 -do- Apollo Balloon

Dilatation Catheter

-do-

264. 00264-MD 28-08-2017 M/s Cor-Med, 2nd

Floor, 38/62 Rehman

Plaza Bank Road,

Saddar, Rawalpindi

Manifold (77-

300000, 77-300006)

Manufacturer by:

M/s Deroyal Industries, Inc. 1703

Highway 33 S New Tazewell, TN 37825

USA


M/s Deroyal Industries, Inc. 200

Debusk LN. Powell, TN 37849 USA

265. 00265-MD 28-08-2017 M/s Health Care

International, Office No

1 1st Floor House No.

42, Street No. 171,

Shahbaz Parkmadina

Colony Baghbanpura,

Lahore

Boosting Catheter Owner operator and manufactured by:

M/s Qxmedical. LLC 2820 Patton Rd

Roseville, MN 55113 USA

266. 00266-MD 28-08-2017 M/s ACP Systems, 13


Iqbal (S.I) Shaheed

Road, Karachi

Medtronic Open

Pivot TM

Heart Valve,

Model 505 DA (AP

360, Aortic)

Manufactured by:



Minneapolis, MN USA 55447




267. 00267-MD 28-08-2017 -do- Relia (VDD Dual

Chamber Permanent

Legal manufacturer:

Pacemaker Model

REVDD01)



Manufacturing site:




Singapore

268. 00268-MD 28-08-2017 -do- Sensia – SR (Model

SES01)

-do-

269. 00269-MD 28-08-2017 -do- Protecta XT VR

(Model D354VRG)

Legal manufacturer:


Parkway N.E., Minneapolis MN 55432

USA.

Manufacturing site:

M/s Medtronic Europe S.a.r.l, Route Du

Molliau 31, Case Postale, 1131

Tolochenaz, Switzerland

270. 00270-MD 28-08-2017 -do- Protecta XT VR

(Model D354VRM)

-do-

271. 00271-MD 28-08-2017 -do- Protecta XT DR

(Model D354DRM)

-do-

272. 00272-MD 28-08-2017 -do- Protecta XT DR

(Model D354DRG)

-do-

273. 00273-MD 28-08-2017 -do- Protecta XT CRT-D

(Model D354TRG)

-do-

274. 00274-MD 28-08-2017 -do- Protecta XT CRT-D

(Model D354TRM)

-do-

275. 00275-MD 28-08-2017 -do- Brava Quad CRT-D

(Model DTBC201)

-do-

276. 00276-MD 28-08-2017 -do- Evera XT DR (Model

DDBB2D4)

-do-

277. 00277-MD 28-08-2017 -do- Viva XT CRT-D

(Model DTBA2D1)

-do-

278. 00278-MD 28-08-2017 -do- Evera XT VR (Model

DVBB2D4)

-do-

279. 00279-MD 28-08-2017 -do- Syncra CRT-P

(Model C2TR01)

-do-

280. 00280-MD 28-08-2017 M/s Universal


Operative Housing


Karachi

Blood Cardioplegia

System with Pre-

Connected CAPIOX®

Cardioplegia (CP50)

M/s Terumo Europe N.V.

Interleuvenlaan 40, 3001 Leuven,

Belgium



Arterial

Cardiopulmonary


65th

Way Arvada, Co USA 80004

Bypass Cannulae

(NA-3436, NA-3437,

NA-3438)

282. 00282-MD 30-08-2017 -do- Venous

Cardiopulmonary

Bypass Cannulae

(RV-40012, RV-

40014, RV-40016,

RV-40018, RV-

40020, RV-40022,

RV-40024, RV-

40026, RV-40028,

RV-40030, RV-

40032, RV-40034,

RV-40036,

RV-40038)

-do-



Apartments, Shadman

II, Ghaus-ul-Azam

Road, Lahore

Verrata Plus Pressure

Guide Wire

Manufactured by :

M/s Volcano Corporation 2870 Kilgore

Rd. Rancho Cordova, CA USA 95670.

M/s Volcano Corporation by Volcarica

S.R.L.Coyol Free Zone and Business

Park Building B37 Coyol, Alajuela

Costa Rica None



BioGlue Surgical

Adhesive

M/s CryoLife, Inc. 1655 Roberts Blvd

NW Kennesaw, GA 30144 USA

285. 00285-MD 06-09-2017 -do- Venous

Cardiopulmonary

Bypass Cannulae

(RDS-61134, RDS-

61137, RDS-61140,

RDS-61146, RDS-

61150)


65th

Way Arvada, CO. 80004 USA

286. 00286-MD 07-09-2017 M/s Cor-Med, 2nd

Floor, 38/62 Rehman

Plaza Bank Road,

Saddar, Rawalpindi

InQwire TM

Guide

Wires (Without

Coating)”

Manufacturing site/ manufactured by:-



84095 USA

287. 00287-MD 07-09-2017 M/s Cardiovascular

Medical System

(CMS), Office No 210-

J-11, M.A Johar Town

Lahore

ALLUNGA PTA

Balloon Catheter

(OTW)”

Manufactured by :-

M/s Qualimed Innovative

Medizinkprodukte GmbH Boschstr. 16

D-21423 Winsen Germany



208, & 208/1, Sector

No. 23, Korangi


Ligamax TM

5mm

Endoscopic Multiple

Clip Applier

Legal manufacturer:-

M/s Ethicon, Endo Surgery, LLC 475

Calle C Guaynabo, PR 00969 USA

Manufactured by:-

(i) M/s Ethicon Endo-Surgery S.A.

De C.V. Planta II, Calle Durango

No.2751, Colonia Lote Bravo

Ciudad Juarez, Chihuahua Mexico

32575.

(ii) M/s Ethicon Endo Surgery, Inc.

3801 University Blvd SE

Albuquerque, NM 87106 USA.

(iii) M/s Ethicon Endo Surgery S.A. De

C.V. Avenida De Last Torres

No.7125 Colonia Salvarcar 118,

Cuidad Juarez, Chihuahua Mexico

32580.

(iv) M/s Ethicon Endo Surgery, Inc.

4545 Creek Rd. Cincinnati, OH

45242 USA.



Al-Amin Plaza, The

Mall, Rawalpindi

Radifocus Glidecath

(Guiding Catheter)”

Marketed By:


Chome, Hatagaya, Shibuya-ku, Tokyo,

Japan.

Manufacturing Site:




Japan

290. 00290-MD 08-09-2017 -do- Tazuna PTCA

Dilatation Catheter)”

-do-

291. 00291-MD 08-09-2017 -do- Hiryu PTCA

Dilatation Catheter

-do-

292. 00292-MD 08-09-2017 -do- Ryujin Plus OTW

PTCA Dilatation

Catheter

-do-

293. 00293-MD 08-09-2017 -do- Eliminate (Aspiration

Catheter)

Manufactured and Marketed By:

M/s Terumo Clinical Supply Co., Ltd, 3

Kawashima-Takehayamachi,

Kakamigahara, GIFU 501-6024, Japan

294. 00294-MD 08-09-2017 -do- FastView (OFDI

Catheter)

Marketed By:


Chome, Hatagaya, Shibuya-ku, Tokyo,

Japan.

Manufacturing Site:




Japan

295. 00295-MD 08-09-2017 -do- Finecross MG (Micro

Catheter)

-do-

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