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CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX

FDA premarket approval P860057/S054 · decided 2009-02-20

Approval details

PMA number
P860057
Supplement
S054
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX
Generic name
replacement Heart-valve
Applicant
Edwards Lifesciences, LLC
Date received
2008-12-22
Decision date
2009-02-20
Days to decision
60 days
Decision code
APPR
Product code
DYE
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
APPROVAL FOR MINOR MODIFICATIONS TO THE 3.8 OZ JAR PACKAGING SYSTEM USED FOR THE MODELS 7000 AND 7000TFX, CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESES AND A NEW NAME AND MODEL NUMBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES MODELS 7100 AND 7100TFX AND ARE INDICATED FOR MITRAL VALVE REPLACEMENT.

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