BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Pulse Generator, External Pacemaker, Dual Chamber

    PMA: P950037 · Supplement: S088 · Decision Apr 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Pulse Generator, External Pacemaker, Dual Chamber
    Trade Name
    RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS
    PMA Number
    P950037
    Supplement Number
    S088
    Device Class
    FDA Class 2
    Product Code
    OVJ
    Generic Name
    Pulse Generator, External Pacemaker, Dual Chamber
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 20, 2011
    Date Received
    October 6, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE; 7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES.

    Classifications

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

    Product Code Device Name
    OVJ Pulse Generator, External Pacemaker, Dual Chamber