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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)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP030035
Supplement NumberS003
Date Received09/30/2004
Decision Date04/29/2005
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 05M-0289
Notice Date 07/26/2005
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the frontier cardiac resynchronization therapy system. These devices are 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling