BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Decision Oct 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
    PMA Number
    P980016
    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 9, 1998
    Date Received
    May 11, 1998
    Expedited Review
    N
    Docket Number
    98M-0907

    Advisory Committee Statement

    Approval for the Medtronic(R) Model 7271 GEM(TM) DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM(TM) DR) Application Software, Medtronic(R) Model 6940 CapSureFix(R) Lead and Model 9466 Patient Magnet. This system 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 loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (Note: the clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies 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)