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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 Liquid CDx (F1LCDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS014
Date Received09/28/2023
Decision Date06/28/2024
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03748641
Supplement TypeNormal 180 Day 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 to expand the intended use of FoundationOne Liquid CDx (F1LCDx) to include a companion diagnostic indication for identifying patients with Prostate Cancer harboring a BRCA1 or BRCA2 alteration who may benefit from treatment with AKEEGA® (niraparib + abiraterone acetate).
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