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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) and LVIS Jr. X
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170013
Supplement NumberS009
Date Received06/10/2022
Decision Date06/28/2022
Product Code QCA 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to place the post-approval study titled LVIS X PAS on hold, because the sponsor does not intend to market the LVIS X and LVIS Jr. X devices in the United States at this time.
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