Guardant360 CDx
FDA premarket approval P200010/S010 · decided 2023-01-27
Approval details
- PMA number
- P200010
- Supplement
- S010
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Guardant360 CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Guardant Health, Inc.
- Date received
- 2022-06-21
- Decision date
- 2023-01-27
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for expanding the indications for use to include the companion diagnostic claim to identify breast cancer patients with ESR1 missense mutations between codons 310-547 for treatment with ORSERDU (elacestrant).
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