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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 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.
 
DeviceSynergy Ablation System
Generic NameSurgical cardiac ablation device, for treatment of atrial fibrillation
ApplicantATRICURE INC.
7555 Innovation Way
Mason, OH 45040
PMA NumberP100046
Supplement NumberS009
Date Received12/10/2018
Decision Date12/31/2018
Product Code OCM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Expand Atricures current manufacturing site to include an additional building located within close proximity to the current manufacturing facility (within 0.3 miles) to conduct distribution, warehousing, and servicing operations currently conducted in the current facility footprint.
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