Exact Sciences Corporation441 Charmany Drivemadison Wi 53719 Pma Numberp130017 Supplement Numbers051 Date Received03 02 2022 Decision Date04 13 2022 Product Code Php Advisory Committee Pathology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Exact Sciences Corporation441 Charmany Drivemadison Wi 53719 Pma Numberp130017 Supplement Numbers051 Date Received03 02 2022 Decision Date04 13 2022 Product Code Php Advisory Committee Pathology Supplement Typereal Time Process 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
Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS051 Date Received03/02/2022 Decision Date04/13/2022 Product Code PHP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Cologuard2022-04-13

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