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

Sirolimus Eluting Stent System - Cobalt Chromium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000111_366c48032ec678b24bc64dbb1280ea85_00cee52ab40dc4d950131a44e5fe5d30. This device is marketed under the brand name Pronova SS - Sirolimus Eluting Stent System- Stainless Steel. The license holder is Vascular Concepts Limited, 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

UID: MFG/MD/2020/000111_366c48032ec678b24bc64dbb1280ea85_00cee52ab40dc4d950131a44e5fe5d30

Brand Name

Pronova SS - Sirolimus Eluting Stent System- Stainless Steel

License Holder

Vascular Concepts Limited

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

Product Information

The Pronova Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo artery lesions (Pronova SS - Sirolimus Eluting Stent System- Stainless Steel) with a reference vessel diameter ranging from 2.0mm to 4.0mm (Pronova SS - Sirolimus Eluting Stent System- Stainless Steel) and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present.