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Balloon Expandable Coronary Stent System - Cobalt Chromium - India CDSCO Medical Device Registration

Balloon Expandable Coronary Stent System - Cobalt Chromium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000107_4cccc20fe8c4905ac089b143457483ee_678158bc7c055724d75a428fbc054ae3. 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
Balloon Expandable Coronary Stent System - Cobalt Chromium
UID: MFG/MD/2021/000107_4cccc20fe8c4905ac089b143457483ee_678158bc7c055724d75a428fbc054ae3

Brand Name

Speed - PTCA Catheters

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

Product Information

The Prozeta Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel diameter ranging from 2.0mm to 4.0mm (Speed - PTCA Catheters) and is intended for treatment of coronary arteries

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DJ Fang

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