PMA P110021S045
- Device
- Sapien Transcatheter Heart Valve (thv)
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S045
- Decision date
- 2014-10-20
Current openFDA PMA Record
- Device
- SAPIEN TRANSCATHETER HEART VALVE (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S045
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-10-20
- Decision code
- OK30
- Date received
- 2014-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.