Cobalt Chromium Coronary Stent System - India CDSCO Medical Device Registration
Cobalt Chromium Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000076_480c36db004746cd8625cbc9ff462bd9_fb76fc3d0ba29145d0151541470adf7c. This device is marketed under the brand name 1. WILMA 2. FINCH & 3.PIPIT. The license holder is Sahajanand Medical Technologies Limited, 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
1. WILMA 2. FINCH & 3.PIPIT
License Holder
Sahajanand Medical Technologies LimitedDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Coronary Stent System are indicated for improving coronary luminal diameter in the following: a. Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions with reference vessel diameters ranging from 2.0 mm to 4.5 mm. b. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with reference vessel diameters ranging from 2.0 mm to 4.5 mm. c. Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions with a reference vessel diameter of 2.0 mm to 4.5 mm
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