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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 Atlas Stent System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH020002
Supplement NumberS058
Date Received01/12/2022
Decision Date01/26/2022
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 
Three changes to the non-patient contacting introducer sheath component of the neuroform atlas stent system: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; 3) tip length specification simplification and change of the nominal length.
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