PMA P100046S018

Device: Synergy Ablation System
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S018
Product code: OCM
Decision date: 2024-03-15
Classification: Cardiovascular
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval for labeling changes.

Current openFDA PMA Record#

Device: Synergy Ablation System
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S018
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2024-03-15
Decision code: APPR
Date received: 2024-02-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval for labeling changes.