PMA P870077S011
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS, MODELS 6625LP/ESR
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S011
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2000-06-16
- Decision code
- OK30
- Date received
- 2000-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN VENDOR SUPPLER FOR THE MATERIAL IDENTIFIED AS POLYESTER.