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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
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP170019
Supplement NumberS014
Date Received12/16/2019
Decision Date06/07/2022
Product Code PQP 
Docket Number 22M-1117
Notice Date 06/14/2022
Advisory Committee Pathology
Clinical TrialsNCT02097810
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic indication for NTRK1, NTRK2, and NTRK3 fusions in patients with solid tumors and for ROS1 fusions in patients with non-small cell lung cancer who may benefit from treatment with ROZLYTREK® (entrectinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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