PMA P140031S132
- Device
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S132
- Product code
- NPT
- Decision date
- 2021-09-03
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- New clean room and preliminary packaging room at the Cartago, Costa Rica facility.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S132
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-09-03
- Decision code
- OK30
- Date received
- 2021-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New clean room and preliminary packaging room at the Cartago, Costa Rica facility.