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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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), LVIS Jr., LVIS EVO
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170013
Supplement NumberS004
Date Received03/12/2021
Decision Date07/28/2022
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 new Low-Profile Visualized Intraluminal Support (LVIS) EVO. The LVIS EVO has a modified design compared to the approved LVIS and LVIS Jr. with a change in the radiopacity profile and shorter flared ends of the stent.
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