Foundation Medicine Inc 150 Second Streetcambridge Ma 02141 Pma Numberp200006 Supplement Numbers002 Date Received08 22 2022 Decision Date09 21 2022 Product Code Pqp 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 Foundation Medicine Inc 150 Second Streetcambridge Ma 02141 Pma Numberp200006 Supplement Numbers002 Date Received08 22 2022 Decision Date09 21 2022 Product Code Pqp 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
Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS002 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
FoundationOne®Liquid CDx2022-09-21

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