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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceEPi-Sense Guided Coagulation System
Generic Namesurgical cardiac ablation device, for treatment of atrial fibrillation
Applicant
AtriCure, Inc.
7555 innovation way
mason, OH 45040
PMA NumberP200002
Date Received01/02/2020
Decision Date04/28/2021
Product Code OCM 
Advisory Committee Cardiovascular
Clinical Trials NCT01984346
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the EPi-Sense Guided Coagulation System is intended for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD); and, in whom the expected benefit from rhythm control outweighs the potential known risks associated with a hybrid procedure such as delayed post-procedure inflammatory pericardial effusions.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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