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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.
 
DeviceTRUPULSE™ Generator
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantBiosense Webster, Inc.
31 Technology Dr.
Suite 200
Irvine, CA 91618
PMA NumberP240006
Supplement NumberS012
Date Received09/30/2025
Decision Date12/23/2025
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a software update to the TRUPULSE™ Generator and an update to the user manual of the nGEN™ Pump to facilitate automatic delivery of irrigation at 30 mL/min upon initiation of energy delivery
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