- Device
- Medtronic CoreValve Evolut R, Medtronic CoreValve Evolut PRO, and Medtronic Evolut PRO+ transcatheter aortic valves (TAV
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S071
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-02-28
- Decision code
- OK30
- Date received
- 2020-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade the supplier manufacturing equipment used to manufacture the suture component of the 23mm TAV in the CoreValve Evolut R System, CoreValve Evolut PRO System and Evolut PRO+ System.