PMA P140031S145
- Device
- SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S145
- Product code
- NPT
- Decision date
- 2022-09-23
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S145
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-09-23
- Decision code
- APPR
- Date received
- 2022-08-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.