The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Isolator® Synergy™ Surgical Ablation System.
|Device Name:||AtriCure Isolator® Synergy™ Surgical Ablation System|
|Classification||Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue|
|Applicant||AtriCure, Inc. 7555 Innovation Way Mason, OH 45040|
AtriCure, Inc. 7555 Innovation Way Mason, OH 45040
|CFR Regulation Number||878.4400 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|