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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 Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
PMA NumberP030035
Supplement NumberS053
Date Received01/22/2009
Decision Date07/15/2009
Product Code
NKE[ Registered Establishments with NKE ]
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 the accent / accent rf implantable pulse generators and anthem / anthem rf crt-ps. The device, as modified, will be marketed under the trade name accent / accent rf implantable pulse generators and anthem / anthem rf crt-ps. The device is indicated for: 1) maintaining synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic atrial fibrillation and have nyha class ii or iii heart failure. 2) the reduction of the symptoms of moderate to severe heart failure (nyha class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction <=35% and a prolonged qrs duration. Implantation of accent, accent rf, anthem and anthem rf devices is indicated in one or more of the following permanent conditions: a) syncope b) presyncope c) fatigue d) disorientation due to arrhythmia/ bradycardia e) or combination of those symptoms. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing (accent model pm2110, accent rf model pm2210, anthem and anthem rf devices only) is indicated for those patients exhibiting: a) sick sinus syndrome b) chronic, symptomatic second- and third-degree av block c) recurrent adams-stokes syndrome d) symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal av and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: a) normal sinus rhythm with only rare episodes of a-v block or sinus arrest b) chronic atrial fibrillation c) severe physical disability. (see approval order for additional approval information).