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.
| Device | EPi-Sense Guided Coagulation System |
| Generic Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Applicant | AtriCure, Inc. |
| Date Received | 2020-01-02 |
| Decision Date | 2021-04-28 |
| PMA | P200002 |
| Supplement | S |
| Product Code | OCM |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AtriCure, Inc. 7555 Innovation Way mason, OH 45040 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200002 | | Original Filing |
| S004 |
2022-09-28 |
Normal 180 Day Track |
| S003 |
2022-09-13 |
Normal 180 Day Track No User Fee |
| S002 |
2022-02-17 |
Normal 180 Day Track |
| S001 |
2021-08-31 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices