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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:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S047 S048 S050 S051 S052 
S053 S054 S055 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S091 S092 S093 S094 S095 S096 S097 S099 S100 S101 S102 
S103 S104 S105 S106 S107 S108 S109 S110 S111 S112 S113 S114 
S115 S116 S117 S118 S120 S121 S122 S123 S124 S125 S126 S127 
S128 S129 S131 S132 S133 S134 
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