BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P970012 · Supplement: S009 · Decision Dec 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC VISION SOFTWARE
    PMA Number
    P970012
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    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.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator