PMA P130009S095
- Device
- Edwards SAPIEN XT Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S095
- Product code
- NPT
- Decision date
- 2018-12-03
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modifications to the glutaraldehyde solution system including additional storage tanks.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN XT Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S095
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2018-12-03
- Decision code
- OK30
- Date received
- 2018-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the glutaraldehyde solution system including additional storage tanks.