CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
FDA premarket approval P860057/S119 · decided 2014-03-14
Approval details
- PMA number
- P860057
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-02-25
- Decision date
- 2014-03-14
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
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