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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 NameNEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS008
Date Received11/24/2004
Decision Date01/18/2005
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
(1) changes to the 2f stabilizer catheter, (2) changes to the neuroform2microdelivery stent system; and (3) development of a neuroform3 microdelivery stent system; as modified, devices will be marketed underthe trade names neuroform2 microdelivery stent system and neuroform3microdelivery stent system, as well as the generic trade name neuroformmicrodelivery stent system.
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