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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 MICRODELIVERY STENT SYSTEM
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
fremont, CA 94538
HDE NumberH020002
Supplement NumberS038
Date Received09/23/2013
Decision Date10/23/2013
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for updating the labeling procedure to specify that the scrapped labels are not to be reprinted without using the reprint form att06776, and 100% of the labels (pouch and carton) are to be checked for critical information including batch number, upn, sizeinformation before application.
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