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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.
 
DeviceVARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)
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 NumberS016
Date Received04/01/2026
Decision Date06/30/2026
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
approval for the Connection Interface Unit (CIU) to be used with the TRUPULSE™ Generator, to introduce a predetermined change control plan (PCCP) (Predetermined Change Control Plan TRUPULSE™ Generator System Version 1.0) for planned hardware and software changes to the TRUPULSE™ Generator and related labeling updates
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