- Device
- EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S074
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-05-01
- Decision code
- OK30
- Date received
- 2020-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase to the established action limits used in the bioburden monitoring process and the establishment of new alert limits.