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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.
 
DeviceSphere-9 Catheter and Affera Ablation 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 NumberP240013
Date Received04/11/2024
Decision Date10/24/2024
Product Codes OAD OAE QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT05120193
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the Sphere-9™ Catheter and Affera™ Ablation System. This device is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year) and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera mapping system.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S004 S005  S001 S002 S003 
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