BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Decision Sep 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    PHYLAX AV ICD SYSTEM
    PMA Number
    P000009
    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
    September 29, 2000
    Date Received
    February 14, 2000
    Expedited Review
    N
    Docket Number
    01M-0042

    Advisory Committee Statement

    APPROVAL FOR THE PHYLAX AV ICD SYSTEM INCLUDING THE PULSE GENERATOR, MODEL NUMBER 122 382 AND PHYLAX AV SOFTWARE CARTRIDGE SWM 1000/I-GAV.2.U, MODEL NUMBER 128 814. THE DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OR MORE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS DUE TO A VENTRICULAR TACHYARRHYTHMIA 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT) NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS ID NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES FOR THIS INDICATION HAVE NOT BEEN CONDUCTED.

    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