• 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
Classification Namepolymeric neurovascular embolization
Generic Namepolymeric neurovascular embolization
7351 kirkwood ln n., suite 112
maple grove, MN 55369
HDE NumberH100002
Date Received04/27/2010
Decision Date04/01/2011
Product Code
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 Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress