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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.
 
DeviceBIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Date Received07/28/2003
Decision Date11/05/2004
Product Code OAD 
Docket Number 04M-0497
Notice Date 11/12/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR FOR THE NAVISTAR/CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS, WHICH INCLUDE THESE MODELS: NAVISTAR THERMOCOOL (MODELS NS75T-BCT-252-HS, NS75T-CCT-252-HS, NS75T-DCT-252-HS, NS75T-FCT-252-HS, NS75TC-BCT-252-HS, NS75TC-CCT-252-HS, NS75TC-DCT-252-HS, AND NS75TC-FCT-252-HS); AND CELSIUS THERMOCOOL (MODELS D7IT-BL-252-RT, D7IT-DL-252-RT, D7IT-FL-252-RT, D7ITC-BL-252-RT, D7ITC-DL-252-RT, AND D7ITC-FL-252-RT). THE BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE NAVISTAR THERMOCOOL CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP/XP NAVIGATION SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S060 S058 S050 S051 S052  S031 S032 S033 S034 S035 S071 
S068 S045 S039 S040 S001 S003 S006 S004 S024 S025 S026 S010 
S014 S030 S002 S005 S036 S037 S057 S061 S062 S069 S070 S066 
S067 S047 S048 S059 S041 S042 S043 S044 S038 S063 S064 S065 
S053 S054 S055 S011 S018 S027 S028 S029 S019 S020 S021 S012 
S007 S008 S009 S022 S023 S072 S078 S079 S073 S081 S074 S075 
S076 S077 S013 S086 S087 S088 S089 S090 S080 S096 S106 S107 
S102 S103 S104 S091 S092 S108 S124 S128 S123 S115 S116 S117 
S118 S131 S083 S084 S085 S082 S099 S109 S097 S094 S095 S100 
S101 S105 S111 S112 S093 S126 S127 S129 S132 S133 S110 S120 
S121 S122 S113 S114 S125 S134 
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