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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceFlow Re-Direction Endoluminal Device (FRED®) System
Generic NameIntracranial aneurysm flow diverter
ApplicantMicroVention, Inc.
35 Enterpricse
Aliso Viejo, CA 92656
PMA NumberP180027
Date Received08/01/2018
Decision Date12/16/2019
Product Code OUT 
Docket Number 19M-5961
Notice Date 12/18/2019
Advisory Committee Neurology
Clinical TrialsNCT01801007
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The Flow Re-Direction Endoluminal Device (FRED®) System. The Flow Re-Direction Endoluminal Device (FRED®) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 5.0 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010