Foundation Medicine Inc 150 Second Street 1st Floorcambridge Ma 02141 Pma Numberp170019 Supplement Numbers035 Date Received06 09 2022 Decision Date07 08 2022 Product Code Pqp Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee 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 Street 1st Floorcambridge Ma 02141 Pma Numberp170019 Supplement Numbers035 Date Received06 09 2022 Decision Date07 08 2022 Product Code Pqp Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee 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 P170019S035 Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS035 Date Received06/09/2022 Decision Date07/08/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	FoundationOne CDx (F1CDx)	2022-07-08