PMA P200002S004

Device: EPi-Sense®, EPi-Sense ST™ Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S004
Product code: OCM
Decision date: 2022-12-27
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: Approval for the Multifunctional Ablation Generator (MAG) as part of the EPi-Sense® and EPi-Sense ST Guided Coagulation System (EPi-Sense).

Current openFDA PMA Record#

Device: EPi-Sense®, EPi-Sense ST™ Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S004
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2022-12-27
Decision code: APPR
Date received: 2022-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Multifunctional Ablation Generator (MAG) as part of the EPi-Sense® and EPi-Sense ST Guided Coagulation System (EPi-Sense).