Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | EPi-Sense Guided Coagulation System |
Generic Name | surgical cardiac ablation device, for treatment of atrial fibrillation |
Applicant | AtriCure, Inc. 7555 innovation way west chester, OH 45040 |
PMA Number | P200002 |
Date Received | 01/02/2020 |
Decision Date | 04/28/2021 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01984346
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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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 |
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