Foundation Medicine Inc

FDA Filings

This page includes the latest FDA filings for Foundation Medicine Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010679023
• FEI Number: 3010679023
• Name: FOUNDATION MEDICINE, INC.
• Owner & Operator: Foundation Medicine, Inc.
• Contact Address: 150 Second St 1st Floor; Cambridge MA 02141 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 150 Second St 1st Floor; Cambridge, MA 02141 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P200006S001 Foundation Medicine, Inc.	FoundationOne Liquid CDx	2022-02-03
PMA P170019S030 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2022-01-19
PMA P170019S028 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2021-11-18
PMA P170019S026 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2021-07-30
PMA P190032S001 Foundation Medicine Inc.	FoundationOne Liquid CDx (F1 Liquid CDx)	2021-07-15
PMA P170019S023 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2021-06-30
PMA P170019S021 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2021-05-28
PMA P200016 Foundation Medicine, Inc.	FoundationOne Liquid CDx	2020-11-06
PMA P200006 Foundation Medicine, Inc.	FoundationOne Liquid CDx (F1 Liquid CDx)	2020-10-26
PMA P170019S020 Foundation Medicine, Inc.	FoundationOne CDx	2020-10-15
PMA P190032 Foundation Medicine Inc.	FoundationOne Liquid CDx (F1 Liquid CDx)	2020-08-26
PMA P170019S019 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2020-07-24
PMA P170019S015 Foundation Medicine, Inc.	FoundationOne CDx	2020-05-19
PMA P170019S018 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2020-05-13
PMA P170019S013 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2020-04-17
PMA P170019S012 Foundation Medicine, Inc.	FoundationOne CDx	2019-11-06
PMA P170019S009 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2019-08-21
PMA P170019S008 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2019-07-01
PMA P170019S004 Foundation Medicine, Inc.	FoundationOne CDx	2019-07-01
PMA P170019S005 Foundation Medicine, Inc.	FoundationOne CDx Assay	2019-04-10
PMA P170019S002 Foundation Medicine, Inc.	FoundationOne CDx	2018-12-18
PMA P170019S003 Foundation Medicine, Inc.	FoundationOne CDx (F1CDx)	2018-10-11
PMA P160018S001 FOUNDATION MEDICINE, INC	FoundationFocus CDx BRCA HRD	2018-04-06
PMN P170019 | PQP FOUNDATION MEDICINE, INC.	FoundationOne CDx	2017-12-15
PMA P170019 Foundation Medicine, Inc.	FoundationOne CDx	2017-11-30
PMN P160018 | PQP FOUNDATION MEDICINE, INC.	FoundationFocus CDxBRCA	2017-01-03
PMA P160018 FOUNDATION MEDICINE, INC	FoundationFocus CDxBRCA	2016-12-19

Similar & Related FDA Registered Companies

• 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
• Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• 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
• 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
• Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200016 Supplement NumberS001 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS007 Date Received08/29/2022 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
• Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS006 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
• 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
• Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS034 Date Received03/18/2022 Decision Date04/13/2022 Product Code PQP  Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS033 Date Received12/23/2021 Decision Date03/16/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	73CG0	FOUNDATION MEDICINE, INC.
CAGE Code	73CG0	FOUNDATION MEDICINE, INC.
S.A.M. Registration	73CG0 [963151076]	FOUNDATION MEDICINE, INC.
SEC	0001488613	Foundation Medicine, Inc. of DELAWARE