PMA P100046S013

Device: AtriCure Synergy Ablation System
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S013
Product code: OCM
Decision date: 2022-11-15
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: Approval for the AtriCure Multifunctional Ablation Generator (MAG) as part of the Synergy Ablation System for use with the Isolator® Synergy Clamp™ (OLL2 and OSL2).

Current openFDA PMA Record#

Device: AtriCure Synergy Ablation System
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S013
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2022-11-15
Decision code: APPR
Date received: 2022-03-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the AtriCure Multifunctional Ablation Generator (MAG) as part of the Synergy Ablation System for use with the Isolator® Synergy Clamp™ (OLL2 and OSL2).