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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.
 
DevicePulseSelect™ Pulsed Field Ablation (PFA) system
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantMedtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP230017
Date Received05/05/2023
Decision Date12/13/2023
Product Code QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT04198701
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PulseSelect™ Pulsed Field Ablation (PFA) System. This device is indicated for cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (episode duration less than 1 year).
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 
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