PMA P870077S019
- Device
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP
- 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 DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870077
- Supplement
- S019
- 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.