BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S043 · Decision Apr 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Artificial Heart
    Trade Name
    SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
    PMA Number
    P030011
    Supplement Number
    S043
    Device Class
    FDA Class 3
    Product Code
    LOZ
    Generic Name
    Artificial heart
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 27, 2016
    Date Received
    March 30, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for customer notifications regarding state of charge for batteries separate from consoles in air transportation.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart