Transcatheter Aortic Valve - India CDSCO Medical Device Registration

Transcatheter Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000064_48fe5c68e995038f500d4fd410b1353a_35b9a32863d5974fce24d62817590c4f. This device is marketed under the brand name Launcher. 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

Transcatheter Aortic Valve

UID: IMP/MD/2019/000064_48fe5c68e995038f500d4fd410b1353a_35b9a32863d5974fce24d62817590c4f

Brand Name

Launcher

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 (Launcher) 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 (Launcher).

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Transcatheter Aortic Valve

Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System

M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India

Class D

Transcatheter Aortic Valve

Brand: Hydra Aortic Valve and Delivery System

Vascular Concepts Limited

Class D

Transcatheter Aortic Valve

Brand: CoreValve Evolut 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 D