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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.
 
DeviceTactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantAbbott Medical
5050 Nathan Lane North
Plymouth, MN 55442
PMA NumberP220013
Date Received08/15/2022
Decision Date05/18/2023
Product Code OAE 
Docket Number 23M-2395
Notice Date 06/14/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT04356040
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the TactiFle Ablation Catheter, Sensor Enabled. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Approval OrderApproval Order
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004  S001 S009 S010 S005 S006 S007 S008 
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