BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P900023 · Supplement: S044 · Decision Jul 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
    PMA Number
    P900023
    Supplement Number
    S044
    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
    July 7, 2006
    Date Received
    January 5, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM.

    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