- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S130
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-09-17
- Decision code
- APPR
- Date received
- 2021-07-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the SAPIEN 3 High or Greater Surgical Risk study