- Device
- CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S009
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 1999-04-13
- Decision code
- OK30
- Date received
- 1999-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.