- Device
- Guardant360 CDx
- Applicant
- Guardant Health, Inc.
- PMA number
- P200010
- Supplement
- S021
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-09-25
- Decision code
- APPR
- Date received
- 2024-11-04
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanding the indications for use to include the companion diagnostic claim to identify breast cancer patients with specific ESR1 mutations for treatment with INLURIYO (imlunestrant).