|
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 |
Supplement Number | S007 |
Date Received | 08/31/2023 |
Decision Date | 11/22/2023 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software. |