BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Decision Aug 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK LEAD SYSTEM
    PMA Number
    P910073
    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
    August 26, 1993
    Date Received
    December 19, 1991
    Expedited Review
    N
    Docket Number
    94M-0064

    Advisory Committee Statement

    Approval for the 0060 Series ENDOTAK® Lead System. The ENDOTAK® Lead System (hereafter referred to as the ENDOTAK® Lead System) consists of the following: the ENDOTAK® C Lead Models 0060, 0062, 0064; Lead Stylet Models 6824 and 6825; ENDOTAK® SQ Patch Lead Model 0063; commercially available AICD™ Y Connector Model 6836; and Model 0056 Bipolar Positive Fixation Lead and Adapter. The ENDOTAK® Lead System is used with commercially available AICD™ Models 15050, 1555, and 1600. The ENDOTAK® Lead System is a transvenous defibrillation leads system and is intended for the treatment of ventricular tacharrhythmias in patients who are at high risk of sudden cardiac death. Such patients are defined as those who have experienced one or more of the following: (1) survived at least one episode of cardiac arrest presumable due to hemodynamically unstable ventricular tachyarrhythmias unassociated with acute myocardial infarction; or (2) recurrent ventricular tachyarrhythmia’s in the absence of such previous arrest and are inducible into sustained hypotensive ventricular tachycardia (VT) or ventricular fibrillation (VF) despite conventional antiarrhythmic drug therapy.A major consideration in choosing the ENDOTAK® Lead System is that it does not require a thoracotomy. The physician should weigh its advantages against the patient’s ability to withstand additional electrophysiological (EP) testing (arrhythmia induction and conversion testing), and a possible thoracotomy, should the lead system prove ineffective.Various factors such as cardiomegaly or drug therapy may necessitate repositioning of the defibrillating leads, or substitution of one lead system for another in order to facilitate arrhythmia conversion. In some cases, reliable arrhythmia conversion may not be obtained with any leads at the available AICD™ energy levels.Bipolar pacmakers may be used with the ENDOTAK® Lead System and AICD™ pulse generator as long as the pacemaker and AICD™ pulse generator do not interact causing AICD™ pulse generator nondetection or false detection.The ENDOTAK® SQ Patch Lead is intended for chronic subcutaneous or submuscular implantation in conjunction with an ENDOTAK® C Lead. The ENDOTAK® SQ Patch Leas is not intended for epicardial or pericardial placement.

    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)