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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.
 
DeviceEXCLUDER BIFURCATED ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N. North Valley Parkway
Phoenix, AZ 85085
PMA NumberP020004
Date Received01/23/2002
Decision Date11/06/2002
Product Code MIH 
Docket Number 02M-0527
Notice Date 12/20/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE EXCLUDER BIFURCATED ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED: 1) ADEQUATE ILIAC/FEMORAL ACCESS 2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-26 MM AND A MINIMUM AORTIC NECK LENGTH OF 15 MM 3) PROXIMAL AORTIC NECK ANGULATION <= 60 DEGREES 4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-13.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM. THE AORTIC AND ILIAC EXTENDER ENDOPROSTHESES ARE INTENDED TO BE USED AFTER DEPLOYMENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS. THESE EXTENSIONS ARE INTENDED TO BE USED WHEN ADDITIONAL LENGTH AND/OR SEALING FOR ANEURISMAL EXCLUSION IS DESIRED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 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 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 
S087 S088 S089 S091 S092 S093 S094 S095 S096 S097 S098 S099 
S100 S101 S102 S103 S104 S105 S106 S108 S109 S110 S111 S112 
S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S136 
S137 S138 S139 S140 S141 S143 S144 S145 S146 S147 S148 S149 
S150 S151 S152 S154 S155 S156 S157 S158 S159 S160 S161 S162 
S163 S164 S165 S166 S167 S168 S170 S171 S172 S173 S174 S175 
S176 S177 S179 S180 S181 S182 S183 S184 S185 S186 S187 S188 
S189 S190 S191 S192 S193 S194 S195 S196 
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