PMA P870077S042
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S042
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-03-22
- Decision code
- OK30
- Date received
- 2012-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.