PMA P010041S017
- Device
- CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2008-10-29
- Generic name
- replacement Heart-valve
- Approval order statement
- ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S017
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2008-10-29
- Decision code
- OK30
- Date received
- 2008-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.