BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S046 · Decision Apr 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
    PMA Number
    P900023
    Supplement Number
    S046
    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 24, 2007
    Date Received
    October 26, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE AB5000 VENTRICLE CANNULA RESTRAINT SYSTEM, EXTENDED SHELF LIFE (2 YEARS) FOR THE AB5000 VENTRICLE, AND RECLASSIFICATION OF A PRECAUTION TO A WARNING FOR THE BVS 5000.

    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