Medtronic Core Valve Evolut R Transcatheter Aortic Valve, Medtronic Core Valve Evolut Pro Transcatheter Aortic Valve
FDA premarket approval P130021/S137 · decided 2023-04-28
Approval details
- PMA number
- P130021
- Supplement
- S137
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medtronic Core Valve Evolut R Transcatheter Aortic Valve, Medtronic Core Valve Evolut Pro Transcatheter Aortic Valve
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2023-04-13
- Decision date
- 2023-04-28
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Implement the use of the Transcatheter Aortic Valve Implantation Solutions Display system for tracking of solution expiration dates.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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