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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 NameWINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
STRYKER CORP.
47900 bayside parkway
fremont, CA 94538
HDE NumberH050001
Date Received01/28/2005
Decision Date08/03/2005
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 005M0308
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the wingspan stent system with gateway pta balloon catheter. This device is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Supplements: S001 S002 S003 S005 S006 S007 S008 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 S042 S045 S046 S047 S048 S049 
S050 S051 S052 S054 S055 S056 S057 S058 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 S088 S089 S090 S091 S092 S093 S094 S095 
S096 S097 S098 S099 S100 S101 
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