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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. N. Valley Pkwy.
Phonix, 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
Predetermined Change Control Plan AuthorizedNo
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: S063 S058 S059  S060 S061 S062 S015 S008 S010 S121 S122 
S123 S064 S065 S066 S054 S006 S007 S005 S034 S035 S036 S028 
S029 S030 S031 S032 S004 S014 S132 S133 S139 S140 S141 S170 
S171 S001 S002 S003 S011 S012 S013 S033 S041 S042 S043 S055 
S037 S038 S039 S040 S016 S018 S019 S020 S050 S051 S048 S056 
S057 S052 S053 S049 S130 S131 S145 S137 S134 S135 S136 S143 
S144 S138 S149 S156 S147 S163 S164 S176 S183 S194 S181 S187 
S188 S189 S193 S198 S201 S204 S155 S152 S154 S148 S150 S151 
S146 S157 S158 S159 S165 S166 S167 S168 S196 S195 S205 S202 
S203 S199 S200 S197 S206 S208 S021 S022 S023 S024 S025 S026 
S027 S067 S104 S105 S106 S108 S109 S118 S119 S120 S124 S087 
S088 S111 S095 S096 S097 S098 S099 S100 S101 S102 S072 S073 
S082 S075 S076 S077 S112 S113 S114 S068 S089 S091 S070 S074 
S044 S045 S046 S047 S115 S116 S117 S081 S103 S175 S078 S079 
S080 S094 S110 S172 S160 S161 S162 S173 S174 S182 S071 S207 
S177 S179 S180 S184 S185 S092 S093 S190 S191 S192 S083 S084 
S085 S086 S186 S125 S126 S127 S128 S129 
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