PMA P200002S012

Device: EPi-Sense Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S012
Product code: OCM
Decision date: 2025-10-07
Classification: Cardiovascular
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: approval of a revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200002.

Current openFDA PMA Record#

Device: EPi-Sense Guided Coagulation System
Applicant: AtriCure, Inc.
PMA number: P200002
Supplement: S012
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2025-10-07
Decision code: APPR
Date received: 2025-07-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of a revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200002.