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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 Dr., 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
Predetermined Change Control Plan AuthorizedNo
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: 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 S135 S136 S137 S138 
S139 S141 S142 S143 S144 S146  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 
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