PMA P130009S093
- Device
- Edwards SAPIEN XT Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S093
- Product code
- NPT
- Decision date
- 2018-09-05
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Adoption of parametric release in the Irvine and Changi manufacturing facilities.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN XT Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S093
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2018-09-05
- Decision code
- OK30
- Date received
- 2018-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adoption of parametric release in the Irvine and Changi manufacturing facilities.