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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 (F1CDx)
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Foundation Medicine, Inc.
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP170019
Supplement NumberS021
Date Received10/29/2020
Decision Date05/28/2021
Product Code PQP 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for FGFR2 fusion/rearrangements in patients with Cholangiocarcinoma who may benefit from treatment with Truseltiq (infigratinib).