BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P980012 · Supplement: S005 · Decision Jan 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    NOVACOR N100PCQ LVAS
    PMA Number
    P980012
    Supplement Number
    S005
    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
    January 2, 2004
    Date Received
    January 27, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNCTION FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.

    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