BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S016 · Decision Aug 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...
    PMA Number
    P000009
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 11, 2005
    Date Received
    June 16, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT INTRACARDIAC ELECTROGRAM (IEGM) SNAPSHOTS OF TACHYCARDIA EVENTS INTO HOME MONITORING TRANSMISSIONS. IN ORDER TO ACCOMPLISH THIS, YOU HAVE REQUESTED THE APPROVAL OF THE LUMOS FAMILY OF ICDS PROGRAMMER SOFTWARE UPGRADES, AND AN UPGRADE TO THE CURRENTLY MARKETED HOME MONITORING SERVICE CENTER.

    Classifications

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

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber