BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S007 · Decision Apr 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Artificial Heart
    Trade Name
    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
    PMA Number
    P030011
    Supplement Number
    S007
    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 28, 2010
    Date Received
    January 15, 2010
    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 THE TRADE NAME CHANGE OF THE SUBJECT DEVICE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART AND IS INDICATED FOR USE IN TRANSPLANT-ELIGIBLE CANDIDATES IN IMMINENT DANGER OF DEATH FROM IRREVERSIBLE BIVENTRICULAR FAILURE.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart