Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000134_dd9e936185c45bb38483da5470752fd4_8cc94b669a425bb039bfe840d47ae0bc. This device is marketed under the brand name Yukon Choice 4. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Yukon Choice 4
License Holder
Translumina Therapeutics LLPDevice Class
Approving Authority
CDSCO
Product Information
The Yukon Chrome PC Sirolimus Eluting Stent is indicated for improving luminal diameter and reducing restenosis for treatment of coronary artery lesions in native coronary arteries ranging from 2.0 mm to 4.0 mm. The Yukon Chrome PC Sirolimus Eluting Cobalt Chromium Coronary Stent System is indicated for intraluminal chronic placement in stenosed coronary artery or aorto-coronary bypass grafts in order to obtain vessel patency following acute or subacute coronary artery obstruction. It is also indicated for restenosis or arterial dissection after PTCA procedure. Patients being considered for stent implantation should be acceptable candidates for coronary balloon angioplasty.
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