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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 NumberS004
Date Received09/12/2018
Decision Date03/25/2020
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Clinical Trials NCT02312856
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for revisions to the instructions for use document to include the 1-year results from the "adjunctive neurovascular support for wide-neck aneurysm embolization and reconstruction (answer)" clinical study.
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