BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P910020 · Supplement: S017 · Decision Feb 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MARATHON PACING SYSYTEM
    PMA Number
    P910020
    Supplement Number
    S017
    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
    February 10, 1997
    Date Received
    August 5, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING

    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