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Pulmonary Valved Conduit - India CDSCO Medical Device Registration

Pulmonary Valved Conduit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000517_80776ba2332ceebdc4786ac42caccf8a_7ebae4366e5c5f850096079e6bbb07c5. 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
Pulmonary Valved Conduit
UID: IMP/MD/2020/000517_80776ba2332ceebdc4786ac42caccf8a_7ebae4366e5c5f850096079e6bbb07c5

Brand Name

Mosaic

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Contegra pulmonary valved conduit is indicated for implantation into patients under 18 years of age, presenting with the following clinical conditions: โ–  Correction or reconstruction of the Right Ventricular Outflow Tract (Mosaic ) in congenital heart malformations (Mosaic ) โ–  Pulmonary valve replacement during the Ross procedure โ–  Replacement of a previously implanted but dysfunctional pulmonary homograft or a failed pulmonary prosthesis

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