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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATRICURE SYNERGY ABLATION SYSTEM
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantAtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
PMA NumberP100046
Supplement NumberS003
Date Received07/12/2013
Decision Date08/26/2015
Product Code OCM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION.
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