BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P100047 · Supplement: S215 · Decision Apr 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HeartWare™ HVAD System
    PMA Number
    P100047
    Supplement Number
    S215
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 29, 2024
    Date Received
    February 14, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the patient manual and instructions for use to add information regarding indicator lights on the controller, elevating text to warnings related to electrical alarms, and including instructions related to restarting the pump using an AC power adapter which were previously provided in a Field Action letter

    Classifications

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

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass