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Sirolimus Eluting Stent System- Stainless Steel - India CDSCO Medical Device Registration

Sirolimus Eluting Stent System- Stainless Steel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000111_7ae5a203ed14c0496690bff6dcf45578_92b186900b6b99d5b0c9dda2a0f631b7. 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- Stainless Steel
UID: MFG/MD/2020/000111_7ae5a203ed14c0496690bff6dcf45578_92b186900b6b99d5b0c9dda2a0f631b7

Brand Name

Pronova SS - Sirolimus Eluting Stent System- Stainless Steel

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

Product Information

The Pronova SS 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 2.5mm 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

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