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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®, EPi-Sense ST™ Guided Coagulation System
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantAtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
PMA NumberP200002
Supplement NumberS004
Date Received09/28/2022
Decision Date12/27/2022
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 the Multifunctional Ablation Generator (MAG) as part of the EPi-Sense® and EPi-Sense ST Guided Coagulation System (EPi-Sense).
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