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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB
Classification Namesurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantATRICURE INC.
PMA NumberP100046
Supplement NumberS002
Date Received05/16/2013
Decision Date06/14/2013
Product Code
OCM[ Registered Establishments with OCM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
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