PMA P010041S008
- Device
- CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2005-05-20
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S008
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-05-20
- Decision code
- OK30
- Date received
- 2005-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.