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
lelocle 2400
HDE NumberH160002
Supplement NumberS008
Date Received04/11/2019
Decision Date09/11/2019
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Clinical Trials NCT02312856
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the pulserider aneurysm neck reconstruction device detachment system indicated for use as a detachment controller to detach the pulserider aneurysm neck reconstruction device implant from the delivery wire.
-
-