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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 NumberS018
Date Received02/16/2024
Decision Date03/15/2024
Product Code OCM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval for labeling changes.
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