PMA P870056S018
- Device
- CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870056
- Supplement
- S018
- Product code
- DYE
- Decision date
- 2005-01-19
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P870056
- Supplement
- S018
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-01-19
- Decision code
- OK30
- Date received
- 2004-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.