BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S042 · Decision May 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
    PMA Number
    P860057
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 7, 2009
    Date Received
    July 9, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYE Replacement Heart-Valve