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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 Dr.
Redwood City, CA 94063
PMA NumberP200010
Supplement NumberS021
Date Received11/04/2024
Decision Date09/25/2025
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT04975308
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 specific ESR1 mutations for treatment with INLURIYO (imlunestrant).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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