Flow Re-Direction Endoluminal (FRED) System

FDA Premarket Approval P180027 S004

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

Conversion of a two-step uv glue process into a 1-step uv glue process for the flow re-direction endoluminal device (fred) system

DeviceFlow Re-Direction Endoluminal (FRED) System
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicroVention, Inc.
Date Received2021-05-03
Decision Date2021-05-25
Product CodeOUT 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention, Inc. 35 Enterpricse aliso Viejo, CA 92656

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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