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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
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS015
Date Received11/01/2023
Decision Date11/14/2024
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne Liquid CDx (F1LCDx) (P190032/S015) to include a companion diagnostic indication to identify patients with non-small cell lung cancer harboring MET single nucleotide variants (SNVs) and insertions and deletions (indels) that lead to MET exon 14 skipping alterations who are eligible for treatment with Tepmetko® (tepotinib).
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