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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEPIC AND ATLAS+ HF CRT-D SYSTEMS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP030054
Supplement NumberS010
Date Received06/06/2005
Decision Date11/18/2005
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 05M-0492
Notice Date 12/19/2005
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the modification of the indications for the epic and atlas+ hf crt-d systems, specifically the maintenance of synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic (permanent) atrial fibrillation and have nyha class ii or iii heart failure. The st. Jude medical the epic and atlas+ hf crt-d systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In patients indicated for an icd, the epic and atlas+ hf crt-d systems are also intended: 1) to provide a reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged qrs duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic (permanent) atrial fibrillation and have nyha class ii or iii heart failure.
Approval Order Approval Order
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