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

Premarket Approval (PMA)
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePipeline Vantage Embolization Device with Shield Technology
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS034
Date Received09/27/2021
Decision Date09/15/2023
Product Code OUT 
Advisory Committee Neurology
Clinical TrialsNCT03873714
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new neurovascular flow-diverting stent and delivery system in the Pipeline product family.
Post-Approval StudyShow Report Schedule and Study Progress
-
-