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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.
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC Inc.
PMA NumberP920015
Date Received04/01/1992
Decision Date12/09/1993
Product Code NVY 
Docket Number 94M-0063
Notice Date 04/19/1994
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductYes
RecallsCDRH Recalls
Approval Order 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.
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