Transcatheter Heart Valve - India CDSCO Medical Device Registration

Transcatheter Heart Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_5f313cd4b1aa3cbe296cc3909c330b1a_eadf5557a11bb616032a6da3e713c656. 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

Transcatheter Heart Valve

UID: IMP/MD/2018/000133_5f313cd4b1aa3cbe296cc3909c330b1a_eadf5557a11bb616032a6da3e713c656

Brand Name

MITRIS RESILIA Mitral Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

1. Indicated for use in patients with heart diseases due to native calcific aortic stenosis at any or all levels of surgical risk for open-heart surgery with age years or above. 2. Indicated for use in patients with symptomatic heart disease due to a falling aortic bioprosthetic valve (MITRIS RESILIA Mitral Valve) who are judged by a heart team to be at high or greater risk for open surgical therapy (i.e, predicated risk of surgical mortality greater than or equal to 8% at 30 days, based on the society of thoracic surgeons (MITRIS RESILIA Mitral Valve) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).