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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 NameNeuroform EZ Stent System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH020002
Supplement NumberS064
Date Received07/25/2025
Decision Date08/20/2025
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 of the modification of the in-process monitoring test for pouch sealing set-up from burst testing to seal peel testing for the neuroform ez stent system and wingspan stent system.
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