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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceATRICURE SYNERGY ABLATION SYSTEM
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantATRICURE INC.
7555 Innovation Way
Mason, OH 45040
PMA NumberP100046
Date Received12/23/2010
Decision Date12/14/2011
Product Code OCM 
Docket Number 11M-0910
Notice Date 12/19/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00560885
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ATRICURE SYNERGY ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR THE ABLATION OF CARDIAC TISSUE FOR THETREATMENT OF PERSISTENT ATRIAL FIBRILLATION (SUSTAINED BEYOND SEVEN DAYS, OR LASTING LESS THAN SEVEN DAYS BUT NECESSITATING PHARMACOLOGIC OR ELECTRICAL CARDIOVERSION) OR LONGSTANDING PERSISTENT ATRIALFIBRILLATION (CONTINUOUS ATRIAL FIBRILLATION OF GREATER THAN ONE YEAR DURATION) IN PATIENTS WHO ARE UNDERGOING OPEN CONCOMITANT CORONARY ARTERY BYPASS GRAFTING AND/OR VALVE REPLACEMENT OR REPAIR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 S005 S002 S007 S003 S008 S006 S009 S010 S016 
S017 S011 S012 S015 S013 S018 
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