CDSCO UID MFG/MD/2018/000028_f4e7229724f6eee02862bbd713475a61_c799e6e2b5a08024249dd9f2bc1a2a40
Transcatheter Heart Valve System
Meril Life Sciences Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: First Brand
Registration details
- UID
- MFG/MD/2018/000028_f4e7229724f6eee02862bbd713475a61_c799e6e2b5a08024249dd9f2bc1a2a40
- Device class
- Class D
- Brand name
- First Brand
- License holder
- Meril Life Sciences Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- 1.Myval - Transcatheter Heart Valve: The Myval- Transcatheter Heart Valve (First Brand) system and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis as judged by a heart team (First Brand) and in patients who are at high risk for open heart surgical therapy (First Brand). 2. Navigator - Transcatheter Heart Valve Delivery System is indicated for delivery of the Transcatheter Heart Valve 3. The Mammoth-Balloon dilatation catheter is indicated for dilatation of native stenotic cardiac valves. It is also indicated for balloon dilatation of the stenotic portion of peripheral vessels and aorta. Further, it is indicated for stenting procedure and pre/post-delivery expansion of stents. 4. Python - Introducer Set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions. 5. Crimper Val-de-Crimp Transcatheter Heart Valve Crimping Tool (First Brand) is intended for crimping of Myval-Transcatheter Heart Valve for implantation. CrocoDial Transcatheter Heart Valve Crimping Tool (First Brand) intended for crimping of Myval - Transcatheter Heart Valve for implantation
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About this record
Transcatheter Heart Valve System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_f4e7229724f6eee02862bbd713475a61_c799e6e2b5a08024249dd9f2bc1a2a40. This device is marketed under the brand name First Brand. The license holder is Meril Life Sciences Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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