ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Premarket Approval P100046 S002

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

Addition of a visual inspection for proximal weld length for the devices, modifications relating to the laser welder for distal and proximal jaw weldments and the addition of a re-welding process for the oll2 and osl2 proximal and distal weldments.

DeviceATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
Classification NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Generic NameSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ApplicantATRICURE INC.
Date Received2013-05-13
Decision Date2013-06-14
PMAP100046
SupplementS002
Product CodeOCM
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ATRICURE INC. 7555 Innovation Way mason, OH 45040

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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