PMA P860057S088
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S088
- Product code
- DYE
- Decision date
- 2012-05-15
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- ADDITIONAL STERILIZATION AND BIOBURDEN REDUCTION PROCESS EQUIPMENT.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S088
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-05-15
- Decision code
- OK30
- Date received
- 2012-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL STERILIZATION AND BIOBURDEN REDUCTION PROCESS EQUIPMENT.