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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
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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