PMA P870077S026
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S026
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2009-01-23
- Decision code
- APPR
- Date received
- 2008-02-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED LABELING TO THE INSTRUCTIONS FOR USE.