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/2023/000783_5f313cd4b1aa3cbe296cc3909c330b1a_61079d199c9c26b87213e051ddd8ad6f. This device is marketed under the brand name Navitor™ Transcatheter Heart Valve. The license holder is M/s St. Jude Medical India Pvt. Ltd, 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/2023/000783_5f313cd4b1aa3cbe296cc3909c330b1a_61079d199c9c26b87213e051ddd8ad6f

Brand Name

Navitor™ Transcatheter Heart Valve

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Navitor™ valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are considered high or extreme surgical risk.