BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S017 · Decision Mar 15, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC VISION SOFTWARE SERIES 4.0
    PMA Number
    P980016
    Supplement Number
    S017
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 15, 2001
    Date Received
    February 22, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM DR (MODEL 9960 SOFTWARE), GEMII VR (MODEL 9965 SOFTWARE), AND GEM II DR (MODEL 9964 SOFTWARE) ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.