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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.
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170013
Supplement NumberS010
Date Received11/09/2022
Decision Date12/09/2022
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
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS).
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