PMA P140031S126
- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S126
- Product code
- NPT
- Decision date
- 2021-02-17
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the shelf life extension from 2 to 3 years.
Current openFDA PMA Record#
- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S126
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-02-17
- Decision code
- APPR
- Date received
- 2020-11-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the shelf life extension from 2 to 3 years.