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CDSCO UID IMP/MD/2022/000266_286a79590e6993c6bb687b04b29aecfc_2f774cb8be7f8e879260c4c497df0f47

Aortic Transcatheter heart valve bio prosthesis, stent-like framework

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·Device Class Class D·India CDSCO·Brand: ACURATE neo2 Aortic valve
Registration details
UID
IMP/MD/2022/000266_286a79590e6993c6bb687b04b29aecfc_2f774cb8be7f8e879260c4c497df0f47
Device class
Class D
Brand name
ACURATE neo2 Aortic valve
License holder
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
Approving authority
CDSCO
Product information
The ACURATE neo2 Aortic Valve, in combination with the ACURATEneo2 Transfemoral Delivery System and the ACURATE neo2 Loading Kit, is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiacsurgeon, to be appropriate for the transcatheter heart valve replacement therapy.
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About this record

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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