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CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

FDA premarket approval P860057/S042 · decided 2009-05-07

Approval details

PMA number
P860057
Supplement
S042
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Generic name
replacement Heart-valve
Applicant
Edwards Lifesciences, LLC
Date received
2007-07-09
Decision date
2009-05-07
Days to decision
668 days
Decision code
APPR
Product code
DYE
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESES, MODEL 3000TFX,INCLUDING CHANGES TO THE ELGILOY BAND AND THE POLYESTER BAND. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CARPENTIER -EDWARDS PERIMOUNT MAGNA EASE PERICARDIALAORTIC BIOPROSTHESES. MODEL 3300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OFTHEIR NATIVE OR PROSTHETIC AORTIC VALVE.

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