Delivery Catheter System - India CDSCO Medical Device Registration

Delivery Catheter System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_6c5a96fb2f9b6013a7d68b42c221abbd_c21919dc50d0d3833f15e8518f32e902. This device is marketed under the brand name Onyx TruCor Zotarolimus-Eluting Coronary Stent System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Delivery Catheter System

UID: IMP/MD/2019/000050_6c5a96fb2f9b6013a7d68b42c221abbd_c21919dc50d0d3833f15e8518f32e902

Brand Name

Onyx TruCor Zotarolimus-Eluting Coronary Stent System

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Medtronic Evolut FX system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Medtronic Evolut FX system is indicated for use in patients with symptomatic heart disease due to failure (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (Onyx TruCor Zotarolimus-Eluting Coronary Stent System)

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Delivery Catheter System

Brand: Enveo Pro

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Class C