BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S051 · Decision Jan 27, 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 BIOPROSTHESIS, MODEL 7000 AND 7000TFX
    PMA Number
    P860057
    Supplement Number
    S051
    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
    January 27, 2009
    Date Received
    November 28, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS, AND FOR A NEW CARTON FOR THE EXISTING 3.8 OZ JAR AND ITS ACCOMPANYING PACKAGING SYSTEMS, AND ASSOCIATED LABELING.

    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