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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.
 
DeviceFlow Re-Direction Endoluminal Device (FRED®) System
Generic NameIntracranial aneurysm flow diverter
ApplicantMicroVention, Inc.
35 Enterpricse
Aliso Viejo, CA 92656
PMA NumberP180027
Supplement NumberS013
Date Received05/08/2025
Decision Date11/02/2025
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the stent surface functionalization manufacturing process and to perform stent pusher loading, packaging, labeling, and sterilization on the FRED X system at the MicroVention Costa Rica manufacturing site located at Zona Franca Coyol Alajuela, Costa Rica.
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