Gyrus Acmi Inc 6675 185th Avenue Neredmond Wa 98052 Pma Numberp180007 Supplement Numbers009 Date Received04 12 2022 Decision Date05 12 2022 Product Code Njk Advisory Committee Anesthesiology 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 Gyrus Acmi Inc 6675 185th Avenue Neredmond Wa 98052 Pma Numberp180007 Supplement Numbers009 Date Received04 12 2022 Decision Date05 12 2022 Product Code Njk Advisory Committee Anesthesiology 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 P180007S009 Gyrus ACMI, Inc.6675 185th Avenue Neredmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SVS Deployment Catheter and Loader	2022-05-12