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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceFlow Re-Direction Endoluminal Device (FRED®) System
Generic Nameintracranial aneurysm flow diverter
MicroVention Terumo
35 enterpricse
aliso viejo, CA 92765
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 Trials NCT01801007
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling