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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/2022/000680_c87d460d00d3564b32bb8aea8cee3662_97ae72bf239a35de9c8ca7590ca686f6. This device is marketed under the brand name Eternia-AB. The license holder is Innvolution Healthcare Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class D
Everolimus Eluting Coronary Stent System
UID: MFG/MD/2022/000680_c87d460d00d3564b32bb8aea8cee3662_97ae72bf239a35de9c8ca7590ca686f6

Brand Name

Eternia-AB

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Everolimus Eluting Coronary Stent system (Eternia-AB) is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (Eternia-AB). Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length โ‰ค 48 mm in native coronary arteries with a reference vessel diameter of 2.00 to 4.50 mm

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