Approval Order Statement APPROVAL FOR THE ST. JUDE MEDICAL EPIC HF SYSTEM AND THE ST. JUDE MEDICAL ATLAS + HF SYSTEM. THESE SYSTEMS ARE INDICATED FOR THE FOLLOWING: THE ST. JUDE MEDICAL EPIC HF AND ATLAS + HF SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. THE EPIC HF AND ATLAS + HF SYSTEMS ARE ALSO INTENDED 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. |