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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.
 
DeviceGlobe® Pulsed Field System
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantKardium, Inc.
8518 Glenlyon Pkwy.
Unit 155
Burnaby V5J OB6
PMA NumberP240044
Date Received12/17/2024
Decision Date08/27/2025
Product Code QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT05462145
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the Globe® Pulsed Field System. This device is indicated for: The Globe® Catheter is indicated for anatomical and electrophysiological mapping and stimulation of cardiac tissue, and for the delivery of ablation energy for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, when used in conjunction with the Globe Pulsed Field System. The Globe® PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.When used for pulsed field ablation, refer to the Instructions for Use of the compatible cardiac ablation catheter for the specific indications for use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 
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