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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 NumberS010
Date Received06/21/2022
Decision Date01/27/2023
Product Code PQP 
Docket Number 23M-0396
Notice Date 02/09/2023
Advisory Committee Pathology
Clinical TrialsNCT03778931
Supplement TypePanel 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 expanding the indications for use to include the companion diagnostic claim to identify breast cancer patients with ESR1 missense mutations between codons 310-547 for treatment with ORSERDU (elacestrant).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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