Guardant360 CDx
FDA premarket approval P200010/S001 · decided 2021-05-21
Approval details
- PMA number
- P200010
- Supplement
- S001
- 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
- 2020-11-20
- Decision date
- 2021-05-21
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval order for extending the label claim to include an indication for RYBREVANT (amivantamab) in non-small cell lung cancer patients with EGFR exon 20 insertions.
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