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/2021/000368_c87d460d00d3564b32bb8aea8cee3662_1852e037526b45b777da2a7024bfe94e. This device is marketed under the brand name Endorser, Patron, Hotron, Flextron. The license holder is Veritas Bioventions 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
Endorser, Patron, Hotron, Flextron
License Holder
Veritas Bioventions Pvt. LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Coronary Stent is indicated for selective implantation and for treatment of acute or threatened closure following intervention in the coronary vasculature, including saphenous vein grafts & is intended to improve coronary luminal diameter. The issues of repeated restenosis are always big problem in metallic stent and to overcome this issue Drug eluting Stents (Endorser, Patron, Hotron, Flextron) are use for angioplasty. The Enovo Everolimus eluting coronary stent system (Endorser, Patron, Hotron, Flextron)is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel. Diameter ranging from 2.00 mm to 4.50 mm and is intended to improve coronary luminal diameter
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