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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.
fremont, CA 94538
HDE NumberH020002
Supplement NumberS003
Date Received03/24/2003
Decision Date04/30/2003
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 02M-0409
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a design change to the 2f stabilizer catheter. The design change involves a 1 -piece molded proximal section (i. E. , luer hub/strain relief/proximaltubing) from a new component supplier.
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