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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.
 
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
Supplement NumberS002
Date Received02/09/2024
Decision Date05/01/2024
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval of software V1.1 that adds a Automated Pulse Trains as a programmable option and minor anomaly updates to the PulseSelect PFA generator model PSG 100
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