- Device
- CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S008
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 1998-10-26
- Decision code
- OK30
- Date received
- 1998-10-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses.