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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 NamePulseRider Aneurysm Neck Reconstruction Device
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International, SARL
chemin-blanc 38
le locle neuchatel CH 24
HDE NumberH160002
Supplement NumberS008
Date Received04/11/2019
Decision Date09/11/2019
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Clinical Trials NCT02312856
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the pulserider aneurysm neck reconstruction device detachment system indicated for use as a detachment controller to detach the pulserider aneurysm neck reconstruction device implant from the delivery wire.
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