PMA P200010S025

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S025
Product code: PQP
Decision date: 2026-05-01
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for expanding the intended use to include a companion diagnostic indication for the detection of ESR1 mutations in patients with breast cancer who may benefit from treatment with VEPPANU (vepdegestrant).

Current openFDA PMA Record#

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S025
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-05-01
Decision code: APPR
Date received: 2025-06-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the intended use to include a companion diagnostic indication for the detection of ESR1 mutations in patients with breast cancer who may benefit from treatment with VEPPANU (vepdegestrant).