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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910073
Date Received12/19/1991
Decision Date08/26/1993
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 94M-0064
Notice Date 04/19/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Approval Order 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.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S010 S011 
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