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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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
PMA NumberP030054
Supplement NumberS019
Date Received11/09/2005
Decision Date03/14/2006
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names epic ii/epic ii+ dr/vr/hf implantable cardioverter defibrillator systems (models v-158, v-255, v-258, and v-355) and model 3307 v. 6. 0c software. The model 3307 v. 6. 0m software interfaces with the above noted pmas. The devices are indicated as follows: the epic ii and epic ii+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For epic ii+ dr devices, af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indication and sinus node dysfunction. In patients indicated for an icd, the epic ii hf system is 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.
Post-Approval StudyShow Report Schedule and Study Progress