CDSCO UID G/28/1396_dd9e936185c45bb38483da5470752fd4_9108a985bed86b37c9b79f25ec808f0e
Sirolimus Eluting Coronary Stent System
Envision Scientific Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: Devoir, Vanquisher
Registration details
- UID
- G/28/1396_dd9e936185c45bb38483da5470752fd4_9108a985bed86b37c9b79f25ec808f0e
- Device class
- Class D
- Brand name
- Devoir, Vanquisher
- License holder
- Envision Scientific Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- • Sirolimus Eluting Coronary Stent System is indicated for treatment of patients with stenosis in Coronary Arteries and for improving and maintaining the coronary luminal diameter in patients including those with symptomatic ischemic disease, stable angina, and unstable angina due to lesions of length ≤ 40 mm in native coronary arteries with a reference diameter from 2.25mm to 5.00mm. • An elective implantation and in the treatment of acute or threatened closure associated with a coronary intervention and in patients undergoing Primary PCI (Devoir, Vanquisher) in patients with Acute Myocardial Infarction. Also, it is indicated in patients with diabetes mellitus and lesions in Coronary Arteries with diffuse proliferative disease.
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About this record
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID G/28/1396_dd9e936185c45bb38483da5470752fd4_9108a985bed86b37c9b79f25ec808f0e. This device is marketed under the brand name Devoir, Vanquisher. 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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