BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980023 · Decision Oct 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
    PMA Number
    P980023
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 27, 1998
    Date Received
    June 8, 1998
    Expedited Review
    N
    Docket Number
    98M-0972

    Advisory Committee Statement

    Approval for the Phylax Implantable Cardioverter Defibrillator (ICD) System: a) ICD PUlse Generator - Phylax XM ICD, model number 121491; Phylax XM Active Housing ICD, model number 121492; Phylax XM Replacement ICD, model number 121162 and mycroPhylax ICD, model number 121493; b) ICD Lead - SPS 75 Lead System, model number 120398; SL-ICD Lead Systems (SL-ICD 75/13, model number 120395, SL-ICD 75/16, model number 120396, SL-ICD 75/18, model number 120397, SL-ICD 100/13, model number 116414, SL-ICD 100/16, model number 118375, SL-ICD118375, SL-ICD 100/18, model number 119077); Kainox SL Lead Systems (Kainox SL 75/13, model number 124219, Kainox SL 75/16, model number 124218, Kainox SL 75/18, model number 124217, Kainox SL 100/13, model number 124238, Kainox SL 100/16, model number 124239, Kainox SL 100/18, model number 124240); Kainox RV 75 Lead System, model number 124005; and (c) Programming and Monitoring System - TMS 1000 Tachyarrhythmia Monitoring System, and Software Module SWM 1000 F00I01. This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia; or recurrent poorly tolerated sustained ventricular tachycardia (VT). Note: the clinical outcome for hemodynamically stable VT patients is not fully know. 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
    LWS Implantable Cardioverter Defibrillator (Non-Crt)