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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.
 
DeviceLVIS
Generic NameIntracranial coil-assist stent
ApplicantMicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
PMA NumberP170013
Supplement NumberS011
Date Received12/18/2023
Decision Date01/17/2024
Product Code QCA 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for manufacturing site change for the component supplier that winds platinum wire into coils for the distal tip of the delivery system pusher of the Flow Re-Direction Endoluminal Device (FRED) System and Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., and LVIS EVO
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