PMA P010041S027
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S027
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2011-05-05
- Decision code
- OK30
- Date received
- 2011-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A THIRD- PARTY SUPPLIER OF THE MOLDED SILICONE INSERTS USED IN THE DEVICES.