- Device
- Edwards EVOQUE Heart Valve (sizes 44mm, 46mm, 48mm, 52mm)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S024
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-03-11
- Decision code
- OK30
- Date received
- 2026-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves