- Device
- Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S177
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2025-08-14
- Decision code
- OK30
- Date received
- 2025-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of two additional functional testers for transcatheter aortic valves