Ventana Medical Systems Inc Roche Tissue Diagnostics 1910 E Innovation Park Drivetucson Az 85755 Pma Numberp210001 Supplement Numbers001 Date Received08 18 2021 Decision Date03 21 2022 Product Code Qnh Advisory Committee Pathology Clinical Trialsnct02460198 Supplement Typenormal 180 Day 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 Roche Tissue Diagnostics 1910 E Innovation Park Drivetucson Az 85755 Pma Numberp210001 Supplement Numbers001 Date Received08 18 2021 Decision Date03 21 2022 Product Code Qnh Advisory Committee Pathology Clinical Trialsnct02460198 Supplement Typenormal 180 Day 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 P210001S001 Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS001 Date Received08/18/2021 Decision Date03/21/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT02460198 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	VENTANA MMR RxDx Panel	2022-03-21