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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) - based Clinical Trial Assay
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 second street
cambridge, MA 02141
PMA NumberP190032
Supplement NumberS008
Date Received09/26/2022
Decision Date12/19/2022
Product Code PQP 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for FoundationOne® Liquid CDx (FILCDx) label expansion to obtain companion diagnostic group labeling claim for patients with non-small cell lung cancer harboring EGFR exon 19 deletions or EGFR exon 21 L858R mutations for treatment with any one of the FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI).
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