CDSCO UID MFG/MD/2021/000058_fae80b5f47ea0652bac823870e6a0345_a85a12bdb538158825ad3b7e813ba242
Coronary Stent System-Stainless Steel Balloon Expandable
M/s Vascular Concepts Ltd.·Device Class Class D·India CDSCO·Brand: Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium
Registration details
- UID
- MFG/MD/2021/000058_fae80b5f47ea0652bac823870e6a0345_a85a12bdb538158825ad3b7e813ba242
- Device class
- Class D
- Brand name
- Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium
- License holder
- M/s Vascular Concepts Ltd.
- Approving authority
- Sub Zonal Bangalore
- Product information
- The Prolink LP Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete coronary de novo artery lesions with a reference vessel diameter ranging from 2.0mm to 4.5mm (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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About this record
Coronary Stent System-Stainless Steel Balloon Expandable is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000058_fae80b5f47ea0652bac823870e6a0345_a85a12bdb538158825ad3b7e813ba242. 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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