|
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 | S011 |
Date Received | 07/02/2019 |
Decision Date | 11/20/2020 |
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 use of an alternate ABS resin material for the OSL2, OLL2 clamp. |