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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)
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
Date Received03/20/2024
Decision Date11/06/2024
Product Code QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT06056557
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump). This device is indicated as follows:VARIPULSE™ CatheterThe VARIPULSE™ Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a TRUPULSE™ Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO™ 3 System. The device is intended for adults 22 years old and above. TRUPULSE™ GeneratorThe generator is indicated for use in conjunction with compatible cardiac ablation catheter to deliver pulsed field (PF) ablation during cardiac ablation procedures.Sterile Interface CableThis cable provides a means to connect a Biosense Webster electrophysiology catheter to the appropriate equipment. The cable may be reused subject to the cleaning and sterilization restrictions detailed in Instructions for Use. nGEN™ PumpThe nGEN™ Pump is a peristaltic pump designed to work with a compatible irrigation tubing set, either independently or with a compatible generator, to deliver irrigation solution to compatible irrigated catheters.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 S014 
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