Everolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Everolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_c87d460d00d3564b32bb8aea8cee3662_d77c83a89b1600be60f67df56247142d. This device is marketed under the brand name First Brand. The license holder is Meril Life Sciences 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
First Brand
License Holder
Meril Life Sciences Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
For Cylindrical Models: It is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo & in-stent restenotic lesions (First Brand) in native coronary arteries with a reference vessel diameter of 2.00 mm to 4.50 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (First Brand) and Stenting procedures. For Taper Model: It is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo & in-stent restenotic lesions (First Brand) in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.50 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (First Brand) and Stenting procedures
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