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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA NumberP130026
Date Received11/29/2013
Decision Date10/24/2014
Product Code
OAE[ Registered Establishments with OAE ]
Docket Number 14M-1736
Notice Date 11/21/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01278953
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the tacticath quartz catheter and tactisysquartz® equipment. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S008 S010