BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S029 · Decision May 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
    PMA Number
    P900023
    Supplement Number
    S029
    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
    May 19, 1999
    Date Received
    April 2, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device.

    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