BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S009 · Decision Nov 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)
    PMA Number
    P000009
    Supplement Number
    S009
    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
    November 13, 2003
    Date Received
    July 3, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LEXOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND SOFTWARE MODIFICATIONS TO THE BELOS FAMILY OF ICDS, THE CARDIAC AIRBAG-T AND THE MICROPHYLAX ICD. THE NEW DEVICE WILL BE MARKETED UNDER THE TRADE NAME LEXOS VR, LEXOS VR-T, LEXOS DR, LEXOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND PROGRAMMER SOFTWARE (A-K00.1.U/4).

    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