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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameCPAX ANEURYSM TREATMENT SYSTEM
Classification Namepolymeric neurovascular embolization
Generic Namepolymeric neurovascular embolization
Applicant
NEUROVASX
7351 kirkwood ln n., suite 112
maple grove, MN 55369
HDE NumberH100002
Date Received04/27/2010
Decision Date04/01/2011
Product Code
OUU
Docket Number 11M0241
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the cpax aneurysm treatment system. This device is indicated for use in the adult population (22 years of age and older) for the treatment of wide-necked large and giant sized cerebral aneurysms > 10 mm that require use of adjunctive assist-devices such as stents or balloons.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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