PMA P200010S002

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S002
Product code: PQP
Decision date: 2021-05-28
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
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).

Current openFDA PMA Record#

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S002
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2021-05-28
Decision code: APPR
Date received: 2020-12-18
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).