PMA P860057S025
- Device
- PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S025
- Product code
- DYE
- Decision date
- 2005-01-19
- Classification
- Replacement Heart-valve
- 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
- PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S025
- 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.