Ventana Medical Systems Inc Roche Tissue Diagnostics

FDA Filings

This page includes the latest FDA filings for Ventana Medical Systems Inc Roche Tissue Diagnostics. 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 P210001 Ventana Medical Systems Inc (Roche Tissue Diagnostics)	VENTANA MMR RxDx Panel	2021-08-17

Similar & Related FDA Registered Companies

• Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS007 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS006 Date Received07/12/2022 Decision Date07/29/2022 Product Code QNH  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS005 Date Received04/28/2022 Decision Date05/20/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT02628067 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• 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