Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix (Pronova XR - Sirolimus Eluting Stent System -Cobalt Chromium Degradable Matrix ) - India CDSCO Medical Device Registration
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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Brand Name
Non-Sterile
License Holder
M/s Vascular Concepts Ltd.Device Class
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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