Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve,
FDA premarket approval P130021/S104 · decided 2021-10-21
Approval details
- PMA number
- P130021
- Supplement
- S104
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve,
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2021-09-22
- Decision date
- 2021-10-21
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Approval for updates regarding flush port orientation, handle rotation, and valve deployment/retrieval timing to the Evolut R, Evolut PRO, and Evolut PRO+ Instructions for Use (IFU) to align to physician training materials and risk documentation.
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