- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S030
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-05-26
- Decision code
- OK30
- Date received
- 2026-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement manufacturing modifications to the inflow and outflow skirt components of the tri-leaflet subassembly of the EVOQUE valve