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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantCARDIOFOCUS, INC.
500 NICKERSON ROAD
MARLBOROUGH, MA 01752
PMA NumberP150026
Date Received07/30/2015
Decision Date04/01/2016
Product Code OAE 
Docket Number 16M-1124
Notice Date 04/12/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT00958165
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The HeartLight® Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 
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