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 NameNEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside pkwy.
fremont, CA 94538
HDE NumberH020002
Supplement NumberS025
Date Received12/06/2010
Decision Date06/10/2011
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
-
-