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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 (F1LCDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS011
Date Received02/23/2023
Decision Date10/11/2023
Product Code PQP 
Docket Number 23M-4783
Notice Date 11/02/2023
Advisory Committee Pathology
Clinical TrialsNCT03915951
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 to include a companion diagnostic indication for the detection of BRAF V600E in patients with non-small cell lung cancer who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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