PMA P870077S041
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSUR MITRAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S041
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-01-19
- Decision code
- OK30
- Date received
- 2011-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.