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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 with Gateway® PTA Balloon Catheter
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Corp.
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH050001
Supplement NumberS102
Date Received12/12/2024
Decision Date11/04/2025
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to add an alternate shipping container for the coating material for the gateway pta balloon catheter.
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