Xvivo Perfusion Inc 3666 S Inca Streetenglewood Co 80110 Pma Numberp180014 Supplement Numbers009 Date Received02 08 2022 Decision Date05 09 2022 Product Code Pho Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Xvivo Perfusion Inc 3666 S Inca Streetenglewood Co 80110 Pma Numberp180014 Supplement Numbers009 Date Received02 08 2022 Decision Date05 09 2022 Product Code Pho Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 P180014S009 XVIVO Perfusion, Inc.3666 S. Inca Streetenglewood, CO 80110 PMA NumberP180014 Supplement NumberS009 Date Received02/08/2022 Decision Date05/09/2022 Product Code PHO  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate	2022-05-09