PMA P130009S097
- Device
- Edwards SAPIEN 3 (XT) Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S097
- Product code
- NPT
- Decision date
- 2019-03-19
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modifications to the bioburden monitoring plan for the Edwards SAPIEN 3 and SAPIEN XT THVs manufactured at the Singapore facility.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 (XT) Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S097
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-03-19
- Decision code
- OK30
- Date received
- 2019-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the bioburden monitoring plan for the Edwards SAPIEN 3 and SAPIEN XT THVs manufactured at the Singapore facility.