Coronary Stent System-Stainless Steel Balloon Expandable - India CDSCO Medical Device Registration
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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Brand Name
Prozeta - Balloon Expandable Coronary Stent System - Cobalt Chromium
License Holder
M/s Vascular Concepts Ltd.Device Class
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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