Pericardial Bioprosthesis - India CDSCO Medical Device Registration

Pericardial Bioprosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_b139746a26dbcd9ee5cf0f9ac7f51844_2b95924f43f7557791bc4265e884f96b. 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

Pericardial Bioprosthesis

UID: IMP/MD/2018/000133_b139746a26dbcd9ee5cf0f9ac7f51844_2b95924f43f7557791bc4265e884f96b

Brand Name

MITRIS RESILIA Mitral Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Magna Ease aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis. The bioprosthesis can be implanted in either the super-annular or intra-annular position

Class D

Brand: Fem-Flex II™ Femoral Arterial Cannula

Class D