PMA P110021S048
- Device
- Edwards Sapien Transcatheter Heart Valve And Acces
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S048
- Decision date
- 2014-11-25
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S048
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-11-25
- Decision code
- OK30
- Date received
- 2014-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.