BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S050 · Decision Apr 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    PARADYM VR MODEL 8250 & DR MODEL 8550
    PMA Number
    P980049
    Supplement Number
    S050
    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
    April 7, 2010
    Date Received
    September 24, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWINGSITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST MANIFESTED BY THE LOSS OFCONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, RECURRENT POORLY TOLERATED SUSTAINEDVENTRICULAR TACHYCARDIA.

    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