Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix - India CDSCO Medical Device Registration

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000058_98e8ecdbc177de13efa5b6d69f834da5_9224a112eb6931454ed4f65209c32447. This device is marketed under the brand name Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium. The license holder is M/s Vascular Concepts Ltd., and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.

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CDSCO Registered

Class Class D

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix

UID: MFG/MD/2021/000058_98e8ecdbc177de13efa5b6d69f834da5_9224a112eb6931454ed4f65209c32447

Brand Name

Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium

License Holder

M/s Vascular Concepts Ltd.

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

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 (Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium) with a reference vessel diameter ranging from 2.5mm to 4.0mm (Prozeta - Balloon Expandable Coronary Stent System - 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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Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix

Brand: Speed - PTCA Catheters

M/s Microtrol Sterilisation Services Private Limited

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix

Coronary Stent System-Stainless Steel Balloon Expandable

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PTCA Catheters

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Sirolimus Eluting Stent System- Stainless Steel

Balloon Expandable Coronary Stent System - Cobalt Chromium

Sirolimus Eluting Stent System - Cobalt Chromium

Sirolimus Eluting Stent System - Cobalt Chromium Degradable Matrix

Coronary Stent System-Stainless Steel Balloon Expandable

Balloon Expandable Covered Stent System- - Stainless Steel Stent With PTFE

PTCA Catheters

PTCA Catheters

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Balloon Expandable Coronary Stent System (“eucaLimus” - Balloon Expandable Coronary Stent System - Sirolimus Eluting Stent )