PMA P110021S044
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S044
- Product code
- NPT
- Decision date
- 2014-10-02
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S044
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-10-02
- Decision code
- OK30
- Date received
- 2014-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.