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 MICRODELIVERY STENT
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS002
Date Received02/10/2003
Decision Date02/28/2003
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Modfications to markerbands: (1) chamfering the edges to reduce the deployment force of the stent and (2) changing the material to 90% platinum with 10% iridium to address the potential cracking of the markerbands during crimping onto the stent loops.
-
-