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 MFG/MD/2020/000228_dd9e936185c45bb38483da5470752fd4_3117233600b5998cc878622c80f418a2. This device is marketed under the brand name Focus np, Abluminus np, Cynosure. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
Focus np, Abluminus np, Cynosure
License Holder
Envision Scientific Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Sirolimus Eluting Coronary Stent System is indicated for treatment of patients with stenosis in coronary arteries. It is indicated for improving and maintaining the coronary luminal diameter in patients. The Sirolimus Eluting Coronary Stent System is indicated to treat coronary artery disease in patients with Diabetes Mellitus and lesion in coronary artery with diffused proliferative disease. The Sirolimus Eluting Coronary Stent System is indicated for treatment of symptomatic ischemic disease with diabetes mellitus due to lesions of length ≤ 52 mm in native coronary arteries with a reference diameter from 2.25mm to 5.00mm
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