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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
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
freemont, CA 94538
HDE NumberH020002
Supplement NumberS005
Date Received06/12/2003
Decision Date07/14/2003
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 02M-0409
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for revised labeling based on a system name change. The system will be now marketed under the trade name neurofomntm2 microdelivery stent system.
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