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

FDA Filings

This page includes the latest FDA filings for 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. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
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 MMR RxDx Panel (Endometrial Cancer with dMMR status)2022-07-21

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