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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 (FICDx)
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 NumberS033
Date Received12/23/2021
Decision Date03/16/2022
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 CDx (FICDx) label expansion to obtain companion diagnostic group labeling claim for non-small cell lung cancer patients 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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