Ventana Medical Systems Inc 1910 E Innovation Park Dr Tucson Az 85755 Pma Numberp100027 Supplement Numbers035 Date Received01 28 2022 Decision Date06 10 2022 Product Code Nyq 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 E Innovation Park Dr Tucson Az 85755 Pma Numberp100027 Supplement Numbers035 Date Received01 28 2022 Decision Date06 10 2022 Product Code Nyq 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 P100027S035 VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS035 Date Received01/28/2022 Decision Date06/10/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	INFORM HER2 Dual ISH DNA Probe Cocktail	2022-06-10