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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 NumberS002
Date Received03/30/2021
Decision Date09/16/2021
Product Code OUT 
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for the FRED X System that contains a novel polymer surface treatment on the neurovascular flow-diverting stent.
Post-Approval StudyShow Report Schedule and Study Progress
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