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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameWingspan Stent System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Corp.
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH050001
Supplement NumberS108
Date Received07/18/2025
Decision Date07/28/2025
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a supplier site change for the wingspan stent laser cutting process and downstream manufacturing steps (laser cutting, ultrasonic bath, spinning andclipping).
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