Ventana Medical Systems Inc 1910 East Innovation Park Dr Tucson Az 85755 Pma Numberp160002 Supplement Numbers016 Date Received01 28 2022 Decision Date06 10 2022 Product Code Pls Advisory Committee Pathology Supplement Type135 Review Track For 30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Ventana Medical Systems Inc 1910 East Innovation Park Dr Tucson Az 85755 Pma Numberp160002 Supplement Numbers016 Date Received01 28 2022 Decision Date06 10 2022 Product Code Pls Advisory Committee Pathology Supplement Type135 Review Track For 30 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 P160002S016 VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PLS  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	VENTANA PD-L1(SP142) Assay	2022-06-10