|
Device | AtriCure Synergy Ablation System |
Generic Name | Surgical cardiac ablation device, for treatment of atrial fibrillation |
Applicant | ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
PMA Number | P100046 |
Supplement Number | S010 |
Date Received | 12/28/2018 |
Decision Date | 06/26/2019 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of labeling updates to include the results of the ABLATE Post Approval Study (PAS) for the AtriCure Synergy Ablation System. |