Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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 NameONYX LIQUID EMBOLIC 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
Supplement NumberS003
Date Received09/09/2013
Decision Date10/09/2013
Product Code
OBA[ Registered Establishments with OBA ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Add an alternate supplier for pyrogen testing.
-
-