BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P060040 · Supplement: S108 · Decision Sep 18, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HeartMate II™ Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit
    PMA Number
    P060040
    Supplement Number
    S108
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 18, 2024
    Date Received
    August 21, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a new test fixture (Patient Cable Redundancy Breakout Fixture)