EPi-Sense Guided Coagulation System

FDA Premarket Approval P200002

Pre-market Approval Supplement Details

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.

DeviceEPi-Sense Guided Coagulation System
Generic NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ApplicantAtriCure, Inc.
Date Received2020-01-02
Decision Date2021-04-28
Product CodeOCM 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address AtriCure, Inc. 7555 Innovation Way mason, OH 45040

Supplemental Filings

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Supplement NumberDateSupplement Type
P200002Original Filing

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