This page includes the latest FDA filings for Foundation Medicine Inc 150 Second Street 1st Floorcambridge Ma 02141 Pma Numberp170019 Supplement Numbers038 Date Received08 29 2022 Decision Date09 27 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.
Device Company | Device | Date |
|---|---|---|
| Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS038 Date Received08/29/2022 Decision Date09/27/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No | FoundationOne CDx (FICDx) | 2022-09-27 |