Flow Re-Direction Endoluminal (FRED) and FRED X System

FDA Premarket Approval P180027 S008

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

DeviceFlow Re-Direction Endoluminal (FRED) and FRED X System
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicroVention, Inc.35 Enterpricsealiso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS008 Date Received03/07/2022 Decision Date03/25/2022 Product Code OUT  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-07
Decision Date2022-03-25
PMAP180027
SupplementS008
Product CodeOUT 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMicroVention, Inc.
35 Enterpricse
aliso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS008 Date Received03/07/2022 Decision Date03/25/2022 Product Code OUT  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
relocation Of Existing Equipment Used For Inner Stent Braiding And Heat Setting For Flow Re-Direction Endoluminal Device (FRED) System And FRED X System To A New Building At The Existing Costa Rica Manufacturing Facility

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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