• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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
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