BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P850051 · Supplement: S065 · Decision May 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable
    Trade Name
    VARIOUS FAMILIES OF PACEMAKERS
    PMA Number
    P850051
    Supplement Number
    S065
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2007
    Date Received
    March 9, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.

    Classifications

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

    Product Code Device Name
    LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable