PMA P860057S119
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S119
- Product code
- DYE
- Decision date
- 2014-03-14
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S119
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-03-14
- Decision code
- OK30
- Date received
- 2014-02-25
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.