Microvention Inc 35 Enterpricsealiso Viejo Ca 92656 Pma Numberp180027 Supplement Numbers007 Date Received01 31 2022 Decision Date03 01 2022 Product Code Out Advisory Committee Neurology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Microvention Inc 35 Enterpricsealiso Viejo Ca 92656 Pma Numberp180027 Supplement Numbers007 Date Received01 31 2022 Decision Date03 01 2022 Product Code Out Advisory Committee Neurology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P180027S007 MicroVention, Inc.35 Enterpricsealiso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS007 Date Received01/31/2022 Decision Date03/01/2022 Product Code OUT  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Flow Re-Direction Endoluminal (FRED®) System, FREDX System	2022-03-01