- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29); Edwards SAPIEN 3 Ultra Transcat
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S207
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-07-28
- Decision code
- OK30
- Date received
- 2026-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the inspection criteria for tissue leaflets