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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-OLL2, OSL2, ASU, ASB
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantAtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
PMA NumberP100046
Supplement NumberS002
Date Received05/13/2013
Decision Date06/14/2013
Product Code OCM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A VISUAL INSPECTION FOR PROXIMAL WELD LENGTH FOR THE DEVICES, MODIFICATIONS RELATING TO THE LASER WELDER FOR DISTAL AND PROXIMAL JAW WELDMENTS AND THE ADDITION OF A RE-WELDING PROCESS FOR THE OLL2 AND OSL2 PROXIMAL AND DISTAL WELDMENTS.
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