- Device
- CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S003
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 1996-10-17
- Decision code
- APPR
- Date received
- 1996-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF YOUR STERILIZATION PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STEERILIZATION PROCESS