BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S038 · Decision Feb 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Artificial Heart
    Trade Name
    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
    PMA Number
    P030011
    Supplement Number
    S038
    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
    February 22, 2016
    Date Received
    December 31, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a location change for a secondary supplier as well as the addition of 3 new machines at the same secondary supplier.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart