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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 parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS006
Date Received09/12/2003
Decision Date12/31/2003
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 the following changes to the ne~iroform stent: 1) addition of a 30mm length for the 3mam, 3. 5mm, 4mm, and 4. 5mm stents; and 2) ani optional 3-interconniect configuration for the 2. 5mim, 3mm, 3. 5mm-i, 4mm, and 4-5mmu stents. The device, as modified, will remain marketed under the trade name neurofonntm2 microdelivery stenit system.
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