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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 NumberS001
Date Received11/20/2020
Decision Date05/21/2021
Product Code PQP 
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 order for extending the label claim to include an indication for RYBREVANT (amivantamab) in non-small cell lung cancer patients with EGFR exon 20 insertions.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling