• 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 NameNEUROFORM MICRODELIVERY STENT
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Date Received04/02/2002
Decision Date09/11/2002
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number O2M-0409
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The neuroform microdelivery stent system is intended for use with emboliccoils for the treatment of wide neck, intracranial, saccular aneurysmsarising from a parent vesel with a diameter of greater than or equal to 2mmand less than or equal to 4. 5mm that are not amendable to treatment withsurgical clipping. Wide neck aneurysms are defined as having a neck of greater than 4mm or a dome-to-neck ratio of less than 2.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S018 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S045 
-
-