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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.
 
DeviceGuardant360 CDx
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantGuardant Health, Inc.
505 penobscot drive
redwood city, CA 94063
PMA NumberP200010
Supplement NumberS008
Date Received04/13/2022
Decision Date08/11/2022
Product Code PQP 
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with ERBB2 activating mutations (SNVs and exon 20 insertions) for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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