BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P920015 · Decision Dec 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    MEDTRONIC(R) TRANSVENE LEAD SYSTEM
    PMA Number
    P920015
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 9, 1993
    Date Received
    April 1, 1992
    Expedited Review
    Y
    Docket Number
    94M-0063

    Advisory Committee Statement

    Approval for the Medtronic Transvene® Lead System. This device is intended for single long-term use and each lead is designed to be used only with a compatible Medtronic implantable tachyarrhytmia control device along with at least one other Medtronic defibrillation lead. The lead system has application where implantable e tachyarrhythmia cardioversion or defibrillation systems are indicated. Current medical research indicates that such patients should: (1) have survived at least one episode of a cardiac arrest presumably due to a ventricular tachyarrhythmia as evidenced by resuscitation using a transthoracic defibrillator. The ventricular tachyarrhythmia should not be caused by an acute myocardial infarction; or (2) in the absence of a of a prior cardiac arrest, have poorly tolerated sustained VT and/or VF, which occurs spontaneously, or can be induced, despite the best antiarrhythmic drug therapy.The natural history of patients with hemodynamically stable sustained VT is not well defined. While this patient population was included in the Transvene® Lead clinical study, no conclusions were drawn from the data obtained on this specific patient group.Prior to Transvene® implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include extensive electrophysiologic testing. Also, extensive electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implantation of the Transvene® System.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes