AtriCure Synergy Ablation System

FDA Premarket Approval P100046 S013

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

DeviceAtriCure Synergy Ablation System
Generic NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ApplicantATRICURE INC.7555 Innovation Waymason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-03-01
Decision Date2022-11-15
PMAP100046
SupplementS013
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
mason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 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  
Approval For The AtriCure Multifunctional Ablation Generator (MAG) As Part Of The Synergy Ablation System For Use With The Isolator® Synergy Clamp™ (OLL2 And OSL2).

Supplemental Filings

Supplement NumberDateSupplement Type
P100046Original Filing
S013 2022-03-01 Normal 180 Day Track
S012 2020-08-03 30-day Notice
S011
S010 2018-12-28 Normal 180 Day Track No User Fee
S009 2018-12-10 30-day Notice
S008 2016-09-01 30-day Notice
S007 2016-06-22 Normal 180 Day Track No User Fee
S006 2014-11-21 Real-time Process
S005 2014-05-21 Normal 180 Day Track No User Fee
S004 2014-04-15 Normal 180 Day Track No User Fee
S003 2013-07-12 Normal 180 Day Track
S002 2013-05-13 30-day Notice
S001 2012-02-14 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00818354010596 P100046 003
00818354010558 P100046 003
00818354010503 P100046 003
00818354010206 P100046 003
30840143902318 P100046 003
30840143902141 P100046 003
30840143903018 P100046 003

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