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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
Guardant Health, Inc.
505 penobscot drive
redwood city, CA 94063
PMA NumberP200010
Supplement NumberS002
Date Received12/18/2020
Decision Date05/28/2021
Product Code PQP 
Docket Number 21M-0494
Notice Date 07/30/2021
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of Guardant360 CDx for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with KRAS G12C mutation for treatment with LUMAKRASTM (sotorasib).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling