|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 Name||ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB|
|Classification Name||surgical cardiac ablation device, for treatment of atrial fibrillation|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| 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.