Flow Re-Direction Endoluminal (FRED®) System

FDA Premarket Approval P180027

Pre-market Approval Supplement Details

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

DeviceFlow Re-Direction Endoluminal (FRED®) System
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicroVention Terumo
Date Received2018-08-01
Decision Date2019-12-16
Product CodeOUT 
Advisory CommitteeNeurology
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention Terumo 35 Enterpricse aliso Viejo, CA 92765
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P180027Original Filing
S004 2021-05-03 30-day Notice
S001 2020-06-19 30-day Notice

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