PMA P140031S098
- Device
- Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S098
- Product code
- NPT
- Decision date
- 2019-10-28
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modifications to the final assembly cleanroom and the associated gowning room.
Current openFDA PMA Record#
- Device
- Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S098
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-10-28
- Decision code
- OK30
- Date received
- 2019-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the final assembly cleanroom and the associated gowning room.