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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
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second St.
1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS025
Date Received12/28/2020
Decision Date11/10/2021
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 for the FoundationOne CDx. The device is intended use is expanded to grant companion diagnostic group labeling claims for melanoma patients harboring BRAF V600E alterations for BRAF inhibitor monotherapy group claim and for BRAF V600E or V600K alterations for BRAF/MEK inhibitor combination group claim.
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