- Device
- EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S098
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-06-30
- Decision code
- OK30
- Date received
- 2021-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new equipment and modification to the manufacturing process flow sequence for a delivery catheter system component.