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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
ApplicantFoundation Medicine, Inc.
150 Second Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS016
Date Received01/21/2020
Decision Date06/16/2020
Product Code PQP 
Docket Number 20M-1612
Notice Date 06/24/2020
Advisory Committee Pathology
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 high tumor mutational burden (TMB) at the cut-off of greater than or equal to 10 mutations per megabase (mut/Mb) in patients with solid tumors who may benefit from treatment with KEYTRUDA® (pembrolizumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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