PMA P860057S066
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S066
- Product code
- DYE
- Decision date
- 2010-02-18
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S066
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2010-02-18
- Decision code
- OK30
- Date received
- 2010-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.