Ventana Medical Systems

FDA Filings

This page includes the latest FDA filings for Ventana Medical Systems. 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 P200019 Ventana Medical Systems	VENTANA MMR RxDx Panel	2021-04-22
De Novo DEN170030 Ventana Medical Systems	VENTANA Anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA Anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA Anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primar	2017-10-27

Similar & Related FDA Registered Companies

• Ventana Medical Systems, Inc.
• Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS009 Date Received01/03/2023 Decision Date01/30/2023 Product Code QKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP220006 Date Received04/25/2022 Decision Date11/14/2022 Product Code QUL  Advisory Committee Clinical TrialsNCT04296890 Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS050 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.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS028 Date Received10/14/2022 Decision Date11/10/2022 Product Code NKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS015 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.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS019 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 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 Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS006 Date Received10/14/2022 Decision Date11/10/2022 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.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS038 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.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS008 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.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS014 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS027 Date Received07/12/2022 Decision Date07/29/2022 Product Code NKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS048 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS037 Date Received07/12/2022 Decision Date07/29/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS007 Date Received07/12/2022 Decision Date07/29/2022 Product Code QKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS018 Date Received07/12/2022 Decision Date07/29/2022 Product Code PKW  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS005 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.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS018 Date Received07/12/2022 Decision Date07/29/2022 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.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS005 Date Received07/12/2022 Decision Date07/29/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS046 Date Received02/16/2022 Decision Date07/21/2022 Product Code MVC  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS012 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS004 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
• Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS006 Date Received02/16/2022 Decision Date07/21/2022 Product Code QFK  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• 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
• VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS025 Date Received01/28/2022 Decision Date06/10/2022 Product Code NKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS005 Date Received01/28/2022 Decision Date06/10/2022 Product Code QKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS011 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 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
• VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS045 Date Received01/28/2022 Decision Date06/10/2022 Product Code MVC  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS003 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
• VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PKW  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code QNH  Advisory Committee Pathology Supplement Type135 Review Track For 30-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
• Ventana Medical Systems Inc (Roche Tissue Diagnostics)

Related Finance Registrations

NCAGE Code	FAQG6	VENTANA MEDICAL SYSTEMS
CAGE Code	FAQG6	VENTANA MEDICAL SYSTEMS