|
Device | EPi-Sense® Guided Coagulation System and EPi-Sense ST™ 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 | S003 |
Date Received | 09/13/2022 |
Decision Date | 10/13/2022 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |