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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
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 NumberS054
Date Received06/21/2024
Decision Date01/16/2025
Product Code PQP 
Docket Number 25M-0269
Notice Date 01/31/2025
Advisory Committee Pathology
Clinical TrialsNCT04775485
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of BRAF V600 mutations and BRAF fusions in patients with pediatric low-grade glioma who may benefit from treatment with OJEMDA (tovorafenib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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