- Device
- Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S107
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Establishment of an in-process shelf life for fixed tissue placed in storage.