BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S056 · Decision Jul 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
    PMA Number
    P860057
    Supplement Number
    S056
    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
    July 9, 2009
    Date Received
    May 1, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW DEVICE TRADE NAME AND MODEL NUMBER TO ADD TO THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS FAMILY. MODEL 7200TFX IS IDENTICAL TO THE PREVIOUSLY APPROVED MODEL 7000TFX WITH THE EXCEPTION OF A DIFFERENT SIZING CONVENTION. THERE ARE NO CHANGES TO THE DIMENSIONS OF THE DEVICE OR THE INDICATIONS FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISMODEL 7200TFX AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC MITRAL VALVES.

    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