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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 NumberS031
Date Received06/16/2026
Decision Date07/06/2026
Product Code PQP 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
modification of the incoming acceptance process for a non-critical component
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