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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesurgical cardiac ablation device, for treatment of atrial fibrillation
Generic Namesurgical cardiac ablation device, for treatment of atrial fibrillation
386 west main street, suite 7
northborough, MA 01532
PMA NumberP100046
Date Received12/23/2010
Decision Date12/14/2011
Product Code
OCM[ Registered Establishments with OCM ]
Docket Number 11M-0910
Notice Date 12/19/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00560885
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008