CDSCO UID IMP/MD/2021/000295_7c57d20bf1ed323c6f06e84eb5a9d921_86fda2f90b985bf5a03fdc7d77900f3f
Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix (Pronova XR - Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix )
M/s Vascular Concepts Ltd.·Device Class Class D·India CDSCO·Brand: Non-Sterile
Registration details
- UID
- IMP/MD/2021/000295_7c57d20bf1ed323c6f06e84eb5a9d921_86fda2f90b985bf5a03fdc7d77900f3f
- Device class
- Class D
- Brand name
- Non-Sterile
- License holder
- M/s Vascular Concepts Ltd.
- Approving authority
- CDSCO
- Product information
- The Pronova XR Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions (Non-Sterile) with a reference vessel diameter ranging from 2.5mm to 4.0mm (Non-Sterile) 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
Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix (Pronova XR - Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000295_7c57d20bf1ed323c6f06e84eb5a9d921_86fda2f90b985bf5a03fdc7d77900f3f. This device is marketed under the brand name Non-Sterile. The license holder is M/s Vascular Concepts Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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