Organox Limitedoxford Science Park Magdalen Centre Robert Robinson Avenueoxford Ox4 4 Pma Numberp200035 Supplement Numbers001 Date Received03 15 2022 Decision Date04 12 2022 Product Code Qqk Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Organox Limitedoxford Science Park Magdalen Centre Robert Robinson Avenueoxford Ox4 4 Pma Numberp200035 Supplement Numbers001 Date Received03 15 2022 Decision Date04 12 2022 Product Code Qqk Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 P200035S001 OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS001 Date Received03/15/2022 Decision Date04/12/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No	OrganOx metra® System	2022-04-12