- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S131
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-08-12
- Decision code
- APPR
- Date received
- 2021-07-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update to add a precaution regarding limitations of deriving gradient estimates from Doppler echocardiography.