Foundation Medicine Inc 150 Second Streetcambridge Ma 02141 Pma Numberp190032 Supplement Numbers008 Date Received09 26 2022 Decision Date12 19 2022 Product Code Pqp 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 Foundation Medicine Inc 150 Second Streetcambridge Ma 02141 Pma Numberp190032 Supplement Numbers008 Date Received09 26 2022 Decision Date12 19 2022 Product Code Pqp 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 Filings

Device Company	Device	Date
PMA P190032S008 Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS008 Date Received09/26/2022 Decision Date12/19/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	FoundationOne Liquid CDx (F1 Liquid CDx) - based Clinical Trial Assay	2022-12-19