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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/2021/000107_98e8ecdbc177de13efa5b6d69f834da5_de8727be5865de99220a0952ccd8cc71. This device is marketed under the brand name Speed - PTCA Catheters. The license holder is M/s Microtrol Sterilisation Services Private 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 Degradable Matrix
UID: MFG/MD/2021/000107_98e8ecdbc177de13efa5b6d69f834da5_de8727be5865de99220a0952ccd8cc71

Brand Name

Speed - PTCA Catheters

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 (Speed - PTCA Catheters) with a reference vessel diameter ranging from 2.5mm to 4.0mm (Speed - PTCA Catheters)and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present

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