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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)
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
Foundation Medicine Inc.
150 second street
cambridge, MA 02141
PMA NumberP190032
Supplement NumberS001
Date Received08/28/2020
Decision Date07/15/2021
Product Code PQP 
Docket Number 21M-0707
Notice Date 07/21/2021
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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