- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S015
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2008-05-23
- Decision code
- APPR
- Date received
- 2008-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.