BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P990046 · Supplement: S005 · Decision Jun 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT
    PMA Number
    P990046
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 7, 2002
    Date Received
    September 24, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO COMBINE THE ATS OPEN PIVOT BILEAFLET HEART VALVE (APPROVED ON OCTOBER 13, 2000 UNDER P990046) WITH THE MEADOX HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT (APPROVED ON MAY 11, 1993 UNDER P840029/S005). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT, MODELS 502AG21 THROUGH 502AG29, AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES, WHERE A REPLACEMENT VALVE AND REPLACEMENT OR REPAIR OF THE AORTA IS REQUIRED.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWQ Heart-Valve, Mechanical