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 NamePulseRider Aneurysm Neck Reconstruction Device
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International, SARL
chemin-blanc 38
le locle neuchatel CH 24
HDE NumberH160002
Supplement NumberS002
Date Received12/28/2017
Decision Date03/26/2018
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site located at sterigenics us, llc, 5725 w. Harold gatty drive, salt lake city, utah 84116 for the sterilization of the pulserider aneurysm neck reconstruction device.
-
-