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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEXCLUDER BIFURCATED ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP020004
Date Received01/23/2002
Decision Date11/06/2002
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 02M-0527
Notice Date 12/20/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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