Guardant360 CDx

FDA Premarket Approval P200010 S001

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.

Pre-market Approval Supplement Details

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.

DeviceGuardant360 CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantGuardant Health, Inc.
Date Received2020-11-20
Decision Date2021-05-21
PMAP200010
SupplementS001
Product CodePQP 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Guardant Health, Inc. 505 Penobscot Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P200010Original Filing
S002 2020-12-18 Panel Track
S001 2020-11-20 Panel Track

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.