BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S037 · Decision Apr 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
    PMA Number
    P900023
    Supplement Number
    S037
    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 28, 2003
    Date Received
    July 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM. THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.

    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