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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGlobe® Catheter and Globe® 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
Supplement NumberS007
Date Received08/03/2026
Decision Date10/27/2026
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for update to the flexible circuits of the Globe® Catheter array
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