BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P830060 · Decision Oct 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
    PMA Number
    P830060
    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 4, 1985
    Date Received
    September 26, 1983
    Expedited Review
    N
    Docket Number
    85M-0504

    Advisory Committee Statement

    Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death. Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previous arrest, have experienced recurrent ventricular tachyarrhythmias and are inducible into sustained hypotensive ventricular tachycardia and/or fibrillation despite conventional antiarrhythmic drug therapy. The patients who meet the above criteria should have also undergone a complete cardiological evaluation that includes electrophysiological testing.

    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)