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 NameLVIS INTRALUMINAL SUPPORT DEVICE
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Micro Vention, Inc.
1311 valencia avenue
tustin, CA 92780
HDE NumberH130005
Supplement NumberS005
Date Received04/05/2017
Decision Date05/10/2017
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
Approval Order Statement 
Approval for a modification to the directions for use (dfu) regarding the magnetic resonance imaging (mri) conditional information. In addition, you provided the supporting performance testing to support the changes to the mri conditional information in the dfu.
-
-