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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 3 Microdelivery Stent System
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH020002
Supplement NumberS047
Date Received01/27/2016
Decision Date02/26/2016
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 
To replace the material for the luer component of the purchased pre-assembled hoop assembly for the neuro renegade hi-flo delivery catheter from pro-fax pd 626 to bormed hd810mo polypropylene resin. The neuro renegade hi-flo packaging hoop will serve as the packaging hoop for the neuroform 3 microdelivery stent system.
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