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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 NumberS013
Date Received10/31/2019
Decision Date04/17/2020
Product Code PQP 
Docket Number 20M-1300
Notice Date 04/21/2020
Advisory Committee Pathology
Clinical TrialsNCT02393248
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order for extending the label claim to include an indication for PEMAZYRE(pemigatinib)in cholangiocarcinoma patients with FGFR2 fusions and select rearrangements.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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