PMA P200010S001

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S001
Product code: PQP
Decision date: 2021-05-21
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order 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.

Current openFDA PMA Record#

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S001
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2021-05-21
Decision code: APPR
Date received: 2020-11-20
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.