BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P100047 · Supplement: S211 · Decision Aug 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HeartWare™ Ventricular Assist System or HeartWare™ System
    PMA Number
    P100047
    Supplement Number
    S211
    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
    August 20, 2023
    Date Received
    May 24, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to update the Instructions for Use (IFU) and Patient Manual (PM) to clarify the instructions regarding the Controller Fault Alarm, the two-year expected useful life of the Primary and Back-up Controller, and the use and care instructions of the backup controller.

    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