EPi-Sense®, EPi-Sense ST™ Guided Coagulation System

FDA Premarket Approval P200002 S004

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

DeviceEPi-Sense®, EPi-Sense ST™ Guided Coagulation System
Generic NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ApplicantAtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS004 Date Received09/28/2022 Decision Date12/27/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-09-28
Decision Date2022-12-27
PMAP200002
SupplementS004
Product CodeOCM 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressAtriCure, Inc.
7555 Innovation Way
west Chester, OH 45040 PMA NumberP200002 Supplement NumberS004 Date Received09/28/2022 Decision Date12/27/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Multifunctional Ablation Generator (MAG) As Part Of The EPi-Sense® And EPi-Sense ST™ Guided Coagulation System (EPi-Sense)

Supplemental Filings

Supplement NumberDateSupplement Type
P200002Original 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 IDPMASupp
10840143901607 P200002 002

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