Annuloplasty Ring - India CDSCO Medical Device Registration

Annuloplasty Ring is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000517_a5401db954f3f81262cc02b03b853190_c9f8ce90c5c18409c37412690686c351. This device is marketed under the brand name Mosaic . The license holder is 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, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Annuloplasty Ring

UID: IMP/MD/2020/000517_a5401db954f3f81262cc02b03b853190_c9f8ce90c5c18409c37412690686c351

Brand Name

Mosaic

License Holder

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

Device Class

Class D

Approving Authority

CDSCO

Product Information

The PROFILE 3D™ Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling

DJ Fang

MedTech Regulatory Expert

Class B

Strata

Brand: Strata NSC Valve

Class C

L/P Shunts

Brand: CSF-Lumboperitoneal Catheter System

Class D