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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 NameVIABAHN ENDOPROSTHESIS
Classification Namestent, superficial femoral artery
Generic Nameperipheral endovascular stent graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Date Received08/27/2004
Decision Date06/14/2005
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 05M-0379
Notice Date 09/23/2005
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 gore viabahn endoprosthesis. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4. 8 to 7. 5 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 S005 S006 S007 S009 S010 S011 
S012 S013 S014 S015 S016 S017 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 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 
S058 S059 S060 S061 S062 S063 S064 S065 S066 
S067 S068 S069 S070 S071 S072 S073 
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