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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
lelocle 2400
HDE NumberH160002
Supplement NumberS010
Date Received02/03/2020
Decision Date04/17/2020
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site located at codman & shurtleff, inc. D/b/a depuy synthes products, inc. , 47709 fremont boulevard, fremont, california 94538, for the assembly, packaging and labeling of the pulserider aneurysm neck reconstruction device and the pulserider detachment system.
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