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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
500 nickerson road
marlborough, MA 01752
PMA NumberP150026
Date Received07/30/2015
Decision Date04/01/2016
Product Code
OAE[ Registered Establishments with OAE ]
Docket Number 16M-1124
Notice Date 04/12/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00958165
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The HeartLight® Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003