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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 (601-01000)
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 NumberS002
Date Received11/17/2025
Decision Date02/18/2026
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
request approval for an update to the Globe Catheter instructions for use (IFU) to provide simplified catheter preparation and air management procedures
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