BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S003 · Decision Jun 11, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC VISION SOFTWARE (MODEL 9953A)
    PMA Number
    P980035
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 11, 1999
    Date Received
    May 19, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification to the Medtronic.Vision Model 9953A Series 1.3 Software, used with the Model 9790 Programmer, to correct a software installation anomaly.