Aortic Transcatheter heart valve bio prosthesis, stent-like framework - India CDSCO Medical Device Registration

Aortic Transcatheter heart valve bio prosthesis, stent-like framework is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000266_286a79590e6993c6bb687b04b29aecfc_2f774cb8be7f8e879260c4c497df0f47. This device is marketed under the brand name ACURATE neo2 Aortic valve. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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