Flow Re-Direction Endoluminal (FRED) System

FDA Premarket Approval P180027 S001

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.

Pre-market Approval Supplement Details

The addition of braiding and furnace equipment for the fred implant at the microvention costa rica facility

DeviceFlow Re-Direction Endoluminal (FRED) System
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicroVention Terumo
Date Received2020-06-19
Decision Date2020-07-17
PMAP180027
SupplementS001
Product CodeOUT 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention Terumo 35 Enterpricse aliso Viejo, CA 92765

Supplemental Filings

Supplement NumberDateSupplement Type
P180027Original Filing
S001 2020-06-19 30-day Notice

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