Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards New South Wales 2065 Pma Numberp990065 Supplement Numbers012 Date Received03 21 2022 Decision Date04 12 2022 Product Code Naw Advisory Committee Radiology 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 Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards New South Wales 2065 Pma Numberp990065 Supplement Numbers012 Date Received03 21 2022 Decision Date04 12 2022 Product Code Naw Advisory Committee Radiology 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 P990065S012 Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW  Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SIR-Spheres Y-90 resin microspheres	2022-04-12