- Device
- Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S076
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-08-17
- Decision code
- APPR
- Date received
- 2020-05-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifying a precaution in the labeling regarding patients with a congenital bicuspid aortic valve.