BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S005 · Decision Dec 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS
    PMA Number
    P000009
    Supplement Number
    S005
    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
    December 20, 2002
    Date Received
    September 25, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) NEW ADDITIONAL PULSE GENERATORS TO THE BELOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND 2) MODIFICATIONS TO THE LEGALLY MARKETED BELOS VR/VR-T ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS DR, DR-T, VR, VR-T ICD SYSTEMS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYMIAS.

    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