BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P970012 · Supplement: S001 · Decision May 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS
    PMA Number
    P970012
    Supplement Number
    S001
    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
    May 21, 1998
    Date Received
    April 6, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an update to the Medtronic.Vision Software Model 9952 - Series 2.0. The update will add the ability to program the Medtronic.Kappa 400 Models K(DR) 401/403, K(SR) 401/403, the Medtronic DX2 Models 7970/7972, and will add Electrophysiological Studies (EPS) capability to the Kappa 400 pacemakers. The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements.

    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