FoundationOne CDx (F1CDx)

FDA Premarket Approval P170019 S035

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceFoundationOne CDx (F1CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation 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
Date Received2022-06-09
Decision Date2022-07-08
PMAP170019
SupplementS035
Product CodePQP 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressFoundation Medicine, Inc.
150 Second Street, 1st Floor
cambridge, 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 Combination ProductNo Approval Order Statement  
The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) 180-day Supplement, Which Requested Approval To Update The Mock Patient Report. Based Upon The Information Submitted, The PMA Supplement Is Approved. You May Begin Commercial Distribution Of The Device As Modified By Your PMA Supplement In Accordance With The Conditions Described Below.

Supplemental Filings

Supplement NumberDateSupplement Type
P170019Original Filing
S035 2022-06-09 Normal 180 Day Track No User Fee
S034 2022-03-18 Normal 180 Day Track No User Fee
S033 2021-12-23 Real-time Process
S032
S031
S030 2021-07-01 Normal 180 Day Track
S029
S028 2021-03-23 Normal 180 Day Track
S027
S026 2020-12-28 Normal 180 Day Track
S025
S024
S023 2020-12-01 Normal 180 Day Track
S022
S021 2020-10-29 Normal 180 Day Track
S020 2020-07-20 Real-time Process
S019 2020-04-27 Real-time Process
S018 2020-04-16 30-day Notice
S017
S016
S015 2019-12-16 Panel Track
S014
S013 2019-10-31 Panel Track
S012 2019-10-21 Special (immediate Track)
S011
S010
S009 2019-07-23 Special (immediate Track)
S008 2019-04-09 Normal 180 Day Track
S007
S006
S005 2018-10-12 Normal 180 Day Track
S004 2018-09-24 Normal 180 Day Track
S003 2018-08-30 Real-time Process
S002 2018-08-24 Real-time Process
S001

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