PMA P140031S141
- Device
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S141
- Product code
- NPT
- Decision date
- 2022-07-28
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S141
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-07-28
- Decision code
- APPR
- Date received
- 2022-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve.