- Device
- Medtronic EnVeo R Delivery Catheter System, Medtronic EnVeo PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S118
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-07-07
- Decision code
- OK30
- Date received
- 2022-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional inspections in the delivery system assembly process.