- Device
- Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System, Evolut R TAV of the Evolut R System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S079
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-07-13
- Decision code
- OK30
- Date received
- 2020-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in tissue cutting parameters for the transcatheter aortic valves (TAVs) of the Evolut PRO, PRO+, and R systems.