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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.
 
DeviceMEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100021
Date Received06/04/2010
Decision Date12/16/2010
Product Code MIH 
Docket Number 11M-0040
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00870051
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ENDURANT STENT GRAFT SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF >= 10MM; 3) INFRARENAL NECK ANGULATION <= 60 DEGREES; 4) DISTAL FIXATION LENGTH OF >= 15 MM; 5) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25 MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S040 S028 S014 S015 S024 S025 S037 S011 S012 S005 S006 
S007 S008 S009 S020 S033 S048 S029 S045 S046 S016 S017 S018 
S026 S038 S013 S019 S034 S035 S036 S052 S053 S027 S059 S057 
S080 S062 S050 S021 S022 S041 S042 S043 S044 S049 S030 S047 
S039 S051 S023 S054 S055 S060 S058 S063 S064 S065 S066 S067 
S068 S076 S083 S075 S089 S090 S091 S103 S094 S095 S107 S097 
S098 S099 S100 S117 S118 S120 S121 S124 S119 S070 S071 S069 
S078 S084 S085 S079 S072 S073 S074 S081 S082 S077 S104 S108 
S109 S110 S111 S114 S115 S105 S106 S112 S113 S092 S093 S101 
S102 S096 S087 S088 S127 S123 S116 S126 S001 S002 S004 S031 
S032 S010 
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