|
Device | EPi-Sense®, EPi-Sense ST™ 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 |
Supplement Number | S004 |
Date Received | 09/28/2022 |
Decision Date | 12/27/2022 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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). |