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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.
 
DeviceGORE TAG THORACIC ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. GORE & ASSOCIATES, INC.
3450 KILTIE LANE
P.O. BOX 2400
FLAGSTAFF, AZ 86003-2400
PMA NumberP040043
Date Received10/04/2004
Decision Date03/23/2005
Product Code MIH 
Docket Number 05M-0320
Notice Date 08/12/2005
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TAG THORACIC ENDOPROSTHESIS AND DELIVERY CATHETER. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS. 2) AORTIC INNER DIAMETER IN THE RANGE OF 23-37 MM. 3) >=2 CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.
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 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 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 S089 S090 S092 S093 S094 S095 S096 S097 S098 S099 S101 
S102 S103 S104 S105 S106 S107 S108 S109 S110 S111 S113 S114 
S115 S116 S117 S118 S119 S120 S121 S123 S124 S125 S126 S127 
S128 S129 S130 S131 S132 S133 S134 S135 
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