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.
 
DeviceLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170013
Supplement NumberS005
Date Received03/30/2021
Decision Date09/16/2021
Product Code QCA 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the LVIS X and LVIS Jr. X that contains a novel polymer surface treatment to the neurovascular coil-assist stent.
Post-Approval StudyShow Report Schedule and Study Progress
-
-