- Device
- EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R, PRO, PRO+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S070
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-12-17
- Decision code
- OK30
- Date received
- 2019-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the acceptance criteria for the visual inspection of the outer shaft of the EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems.