• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 PMA to get an up-to-date view of this device.
 
Trade NamePIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE
Classification Nameintracranial aneurysm flow diverter
ApplicantEV3 NEUROVASCULAR
PMA NumberP100018
Supplement NumberS007
Date Received04/11/2013
Decision Date05/09/2013
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change for the protective coil of the pipeline embolization device delivery system.
-
-