- Device
- Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S184
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative raw material supplier for the radiopaque marker used in delivery catheter systems