Synergy Ablation System

FDA Premarket Approval P100046 S012

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

To expand the existing manufacturing controlled room used for device packaging

• Device: Synergy Ablation System
• Generic Name: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
• Applicant: ATRICURE INC.
• Date Received: 2020-08-03
• Decision Date: 2020-08-14
• PMA: P100046
• Supplement: S012
• Product Code: OCM
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ATRICURE INC. 7555 Innovation Way mason, OH 45040

Supplemental Filings

Supplement Number	Date	Supplement Type
P100046		Original 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 ID	PMA	Supp
00818354010596	P100046	003
00818354010558	P100046	003
00818354010503	P100046	003
00818354010206	P100046	003
30840143902318	P100046	003
30840143902141	P100046	003
30840143903018	P100046	003