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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 NumberS025
Date Received06/18/2025
Decision Date05/01/2026
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 expanding the intended use to include a companion diagnostic indication for the detection of ESR1 mutations in patients with breast cancer who may benefit from treatment with VEPPANU (vepdegestrant).
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