Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business Technology Parkcruiserath Roadblanchardstown D15 T Pma Numberp860003 Supplement Numbers106 Date Received02 09 2022 Decision Date03 11 2022 Product Code Lnr Advisory Committee Gastroenterology Urology 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 Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business Technology Parkcruiserath Roadblanchardstown D15 T Pma Numberp860003 Supplement Numbers106 Date Received02 09 2022 Decision Date03 11 2022 Product Code Lnr Advisory Committee Gastroenterology Urology 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 P860003S106 Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS106 Date Received02/09/2022 Decision Date03/11/2022 Product Code LNR  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO	2022-03-11