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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.
 
DeviceNAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP040036
Date Received08/19/2004
Decision Date08/11/2006
Product Code LPB 
Docket Number 06M-0374
Notice Date 09/12/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS WHICH INCLUDE MODELS N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, AND N175TCJH. THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES, WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR, ARE INDICATED FOR THE TREATMENT OF RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS.THE NAVISTAR THERMOCOOL CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP / XP NAVIGATION SYSTEM, AND CAN BE USED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S045 S041 S033 S035 S036  S043 S023 S024 S026 S053 S029 
S001 S002 S017 S019 S007 S008 S003 S027 S028 S040 S046 S051 
S052 S049 S050 S044 S030 S031 S032 S047 S048 S037 S038 S039 
S013 S020 S021 S022 S014 S009 S004 S005 S006 S015 S016 S054 
S059 S055 S056 S057 S062 S063 S058 S066 S074 S075 S070 S071 
S072 S086 S090 S085 S080 S081 S093 S061 S060 S068 S067 S064 
S065 S069 S073 S076 S077 S089 S091 S094 S095 S082 S083 S084 
S078 S079 S087 S096 
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