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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
Applicant
Foundation Medicine, Inc.
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP170019
Supplement NumberS017
Date Received01/31/2020
Decision Date10/23/2020
Product Code PQP 
Docket Number 20M-2128
Notice Date 10/26/2020
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 order to expand the intended use of FoundationOne®CDx (F1CDx) to include NTRK1/2/3 fusions in patients with solid tumors who may benefit from treatment with VITRAKVI® (larotrectinib).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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