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

FDA Premarket Approval P200002 S003

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® Guided Coagulation System and EPi-Sense ST™ Coagulation System
Generic NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ApplicantAtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-09-13
Decision Date2022-10-13
PMAP200002
SupplementS003
Product CodeOCM 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressAtriCure, Inc.
7555 Innovation Way
west Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
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

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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