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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 S031 S032 S024 S025  S037 S001 S002 S004 S005 S006 
S007 S008 S009 S010 S014 S015 S016 S050 S030 S026 S039 S052 
S053 S055 S059 S060 S062 S063 S011 S012 S029 S033 S048 S045 
S046 S020 S038 S017 S018 S019 S013 S041 S042 S043 S044 S049 
S034 S035 S036 S021 S022 S047 S023 S027 S028 S051 S058 S064 
S065 S054 S057 S068 S077 S080 S083 S095 S106 S107 S108 S109 
S094 S089 S090 S091 S092 S102 S103 S112 S113 S115 S069 S070 
S071 S066 S067 S084 S085 S076 S075 S079 S078 S072 S073 S074 
S081 S082 S097 S098 S099 S110 S111 S118 S114 S093 S087 S088 
S105 S100 S101 S096 S104 S119 S116 S117 S120 
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