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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceFoundationOne Liquid CDx (F1 Liquid CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS010
Date Received11/22/2022
Decision Date06/08/2023
Product Code PQP 
Docket Number 23M-2917
Notice Date 07/14/2023
Advisory Committee Pathology
Clinical TrialsNCT02928224
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the FoundationOne Liquid CDx (F1 Liquid CDx). The device expands the indications for use to include a companion diagnostic indication for the detection of BRAF V600E alteration in patients with metastatic colorectal cancer (CRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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