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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.
 
DeviceEPi-Sense Guided Coagulation System
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantAtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
PMA NumberP200002
Supplement NumberS007
Date Received08/31/2023
Decision Date11/22/2023
Product Code OCM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.
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