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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
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS005
Date Received08/15/2022
Decision Date05/03/2023
Product Code PQP 
Docket Number 23M-1887
Notice Date 05/15/2023
Advisory Committee Pathology
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 EGFR exon 20 insertions in patients with non-small cell lung cancer who may benefit from treatment with EXKIVITY® (mobocertinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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