- Device
- 9600TFX Edwards SAPIEN 3 Transcatheter Heart Valves, 9750TFX Edwards SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S134
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in sampling plan for in-process inspection of the cloth skirt.