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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL 105-8101-500
Classification Namepolymerizing, neurovascular embolization material
Generic Namepolymerizing, neurovascular embolization material
Applicant
EV3 INC
9775 toledo way
irvine, CA 92618
HDE NumberH060003
Date Received03/20/2006
Decision Date04/11/2007
Product Code
OBA[ Registered Establishments with OBA ]
Docket Number 07M-1056
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the onyx* liquid embolic system (onyx'd hd-500). This device is indicated for treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (> 4 mm) or with adome-to-neck ratio < 2 that are not amenable to treatment with surgical clipping.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 
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