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
S008 2022-03-07 30-day Notice
S007 2022-01-31 30-day Notice
S006 2021-11-23 Real-time Process
S005
S004 2021-05-03 30-day Notice
S003
S002
S001 2020-06-19 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00842429114490 P180027 002
00842429114339 P180027 002
00842429114322 P180027 002
00842429114315 P180027 002
00842429114308 P180027 002
00842429114292 P180027 002
00842429114285 P180027 002
00842429114278 P180027 002
00842429114261 P180027 002
00842429114254 P180027 002
00842429114247 P180027 002
00842429114230 P180027 002
00842429114223 P180027 002
00842429114346 P180027 002
00842429114353 P180027 002
00842429114360 P180027 002
00842429114483 P180027 002
00842429114476 P180027 002
00842429114469 P180027 002
00842429114452 P180027 002
00842429114445 P180027 002
00842429114438 P180027 002
00842429114421 P180027 002
00842429114414 P180027 002
00842429114407 P180027 002
00842429114391 P180027 002
00842429114384 P180027 002
00842429114377 P180027 002
00842429114216 P180027 002

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