PMA P140031S133
- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S133
- Product code
- NPT
- Decision date
- 2021-08-31
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Change to the receiving inspection for the Final Stopper component of the Crimp Stopper.
Current openFDA PMA Record#
- Device
- SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S133
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the receiving inspection for the Final Stopper component of the Crimp Stopper.