Ventana Medical Systems Inc 1910 E Innovation Park Dr Tucson Az 85755 Pma Numberp100027 Supplement Numbers036 Date Received02 16 2022 Decision Date07 21 2022 Product Code Nyq Advisory Committee Pathology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numbers036 Date Received02 16 2022 Decision Date07 21 2022 Product Code Nyq Advisory Committee Pathology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P100027S036 VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS036 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	INFORM HER2 Dual ISH DNA Probe Cocktail	2022-07-21