- Device
- EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S088
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-07-15
- Decision code
- APPR
- Date received
- 2021-03-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of the Optimized PCA Sterilization Cycle