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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 Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS011
Date Received10/17/2019
Decision Date05/06/2020
Product Code PQP 
Docket Number 20M-1358
Notice Date 05/08/2020
Advisory Committee Pathology
Clinical TrialsNCT02414139
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 detection of MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping in non-small cell lung cancer patients who may benefit from treatment with TABRECTA (capmatinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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