CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
FDA premarket approval P860057/S126 · decided 2014-08-11
Approval details
- PMA number
- P860057
- Supplement
- S126
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-05-23
- Decision date
- 2014-08-11
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A RECONFIGURATION OF VALVE STENTS, WIREFORMS, AND LEAFLET ASSEMBLIES, AS WELL AS MODIFICATIONS TO THE LABELING.
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