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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 NumberS052
Date Received12/19/2023
Decision Date08/30/2024
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03732820
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 CDx (F1CDx) (P170019/S052) and FoundationOne Liquid CDx (F1LCDx) (P190032/S016) to include a companion diagnostic indication to identify patients with prostate cancer with BRCA1/2 alterations for the treatment with LYNPARZA (olaparib) in combination with abiraterone.
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