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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 CDx, F1CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second St.
1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS039
Date Received01/30/2023
Decision Date10/11/2023
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03915951
Supplement TypeNormal 180 Day 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 order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) 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).
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