- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S027
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-04-08
- Decision code
- OK30
- Date received
- 2005-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.