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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 (F1 Liquid CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second St.
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS023
Date Received05/31/2024
Decision Date10/10/2024
Product Code PQP 
Advisory Committee Pathology
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) (P190032/S023) to include a companion diagnostic indication to identify patients with breast cancer with PIK3CA-mutations for treatment with ITOVEBI (inavolisib) in combination with palbociclib and fulvestrant.
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