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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.
 
DeviceEP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Date Received06/24/2002
Decision Date08/25/2003
Product Code OAD 
Docket Number 03M-0427
Notice Date 09/17/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM. THE BLAZER II XP CARDIAC ABLATION CATHETER IS INDICATED FOR USE WITH THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S030 S031  S026 S027 S028 S029 S052 S053 S040 S033 S081 
S082 S067 S049 S050 S051 S036 S058 S059 S071 S072 S008 S010 
S001 S002 S003 S004 S022 S020 S021 S025 S023 S018 S014 S015 
S007 S087 S088 S090 S094 S098 S099 S100 S101 S032 S043 S044 
S045 S046 S047 S048 S054 S064 S074 S075 S076 S077 S037 S038 
S068 S035 S060 S061 S062 S063 S034 S065 S066 S078 S079 S080 
S055 S056 S057 S069 S070 S039 S042 S011 S012 S013 S017 S005 
S006 S024 S019 S083 S084 S085 S086 S102 S103 S104 S095 S096 
S097 S092 S093 S091 S108 S109 S121 S127 S117 S118 S119 S120 
S130 S133 S129 S138 S105 S110 S111 S106 S107 S112 S113 S114 
S128 S122 S123 S124 S125 S126 S115 S116 S136 S134 S135 S132 
S139 S137 S142 S143 S140 
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