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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 St.
1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS030
Date Received07/01/2021
Decision Date01/19/2022
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 to expand the intended use of FoundationOne CDx (F1CDx) to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for identifying patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, who may benefit from treatment with atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib.
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