Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile) - India CDSCO Medical Device Registration

Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000521_39e15c99104411f693e2b1439017227c_4b3d74c0cf5c995670db7ea5e6694de7. This device is marketed under the brand name Cobalt Chromium. The license holder is Vascular Concepts Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile)

UID: IMP/MD/2019/000521_39e15c99104411f693e2b1439017227c_4b3d74c0cf5c995670db7ea5e6694de7

Brand Name

Cobalt Chromium

License Holder

Vascular Concepts Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Pronova XR Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo artery lesions (Cobalt Chromium) with a reference vessel diameter ranging from 2.5mm to 4.0mm (Cobalt Chromium)and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present

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L605 Sirolimus Eluting Stent

Brand: Cobalt Chromium

Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India

Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

L605 Sirolimus Eluting Stent

Balloon Expandable Coronary Stent System - Cobalt Chromium (Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium )

Coronary Stent System- Stainless Steel Balloon Expandable (Prolink LP - Coronary Stent System- Stainless Steel Balloon Expandable )

Coronary Stent (Prolink -Coronary Stent )

Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix (Pronova XR - Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix )

PTCA Catheters (Speed - PTCA Catheters )

Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile)

Drug Eluting Stent (Sirolimus Eluting Coronary Stent - Non-Sterile)

Sirolimus Eluting Stent System - (Pronova - Sirolimus Eluting Stent System - )

Sirolimus Eluting Stent System- Stainless Steel (Pronova SS - Sirolimus Eluting Stent System- Stainless Steel )

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix

Sirolimus Eluting Stent System- Stainless Steel

Sirolimus Eluting Stent System - Cobalt Chromium

Peripheral Stent System- Self Expandable Nitinol Stent (Resistant- Self Expandable Nitinol Stent )

Coronary Stent - Aortic Stent-Self Expandable Nitinol Stent (mc-a Aortic Stent- Self Expandable Nitinol Stent )

Delivery System(Cocoon PFO- Delivery System- Cocoon PFO- Occluder Accessory Set , Cocoon PFO- Delivery System- Delivery Cable )

Delivery System(Cocoon Septal , Cocoon Duct , Cocoon Delivery Cable )

Septal Occluder(Cocoon Septal Occluder )

Delivery System(Cocoon VSD- Delivery System- Cocoon VSD Occluder Accessory Set , Cocoon VSD- Delivery System- Delivery Cable including Cable Sheath )

Duct Occluder(Cocoon Duct Occluder )