PMA P200010S024

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S024
Product code: PQP
Decision date: 2026-09-04
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for expanding the indications for use to include a companion diagnostic claim for the detection of ESR1 mutations in patients with breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant).

Current openFDA PMA Record#

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S024
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-09-04
Decision code: APPR
Date received: 2025-05-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the indications for use to include a companion diagnostic claim for the detection of ESR1 mutations in patients with breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant).