- Device
- EnVeo PRO Delivery Catheter System (ENVPRO-16-US), Evolut PRO+ Delivery Catheter System (D-EVPROP2329US, D-EVPROP34US),
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S181
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional, alternative external Process Challenge Device (ePCD) for routine monitoring of the ethylene-oxide-sterilization process and reduction the incubation time of the proposed ePCD from the standard 7 days to 4 days