Valve System
- UID
- IMP/MD/2018/000133_59affb4d0c3082dbd602d4c89860e6d5_22d04dd17840e96439d19a8a00597689
- Device class
- Class D
- Brand name
- MITRIS RESILIA Mitral Valve
- License holder
- Edwards Lifesciences (India) Private Limited,
- Approving authority
- CDSCO
- Product information
- Indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve. These devices are also intended for use in patients with a previously implanted aortic valve that requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced with the model 8300AB valve
Valve System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_59affb4d0c3082dbd602d4c89860e6d5_22d04dd17840e96439d19a8a00597689. This device is marketed under the brand name MITRIS RESILIA Mitral Valve. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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