Valve System - India CDSCO Medical Device Registration

Valve System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_59affb4d0c3082dbd602d4c89860e6d5_22d04dd17840e96439d19a8a00597689. This device is marketed under the brand name MITRIS RESILIA Mitral Valve. The license holder is Edwards Lifesciences (India) 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

Valve System

UID: IMP/MD/2018/000133_59affb4d0c3082dbd602d4c89860e6d5_22d04dd17840e96439d19a8a00597689

Brand Name

MITRIS RESILIA Mitral Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve. These devices are also intended for use in patients with a previously implanted aortic valve that requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced with the model 8300AB valve

Class D

Transcatheter Heart Valve

Brand: MITRIS RESILIA Mitral Valve

Edwards Lifesciences (India) Private Limited,

Class D

Brand: Fem-Flex II™ Femoral Arterial Cannula

Class D