- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S206
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-07-02
- Decision code
- OK30
- Date received
- 2026-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of a tissue thickness measurement step from the Biosorting process