EPi-Sense Guided Coagulation System

FDA Premarket Approval P200002 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the 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

• Device: EPi-Sense Guided Coagulation System
• Generic Name: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
• Applicant: AtriCure, Inc.
• Date Received: 2021-08-31
• Decision Date: 2022-01-10
• PMA: P200002
• Supplement: S001
• Product Code: OCM
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review: No
• Combination Product: No
• Applicant Address: AtriCure, Inc. 7555 Innovation Way mason, OH 45040

Supplemental Filings

Supplement Number	Date	Supplement Type
P200002		Original Filing
S004	2022-09-28	Normal 180 Day Track
S003	2022-09-13	Normal 180 Day Track No User Fee
S002	2022-02-17	Normal 180 Day Track
S001	2021-08-31	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
10840143901607	P200002	002