BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S005 · Decision Dec 23, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERS
    PMA Number
    P980035
    Supplement Number
    S005
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 1999
    Date Received
    November 30, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices). The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry.