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Device | FoundationOne Liquid CDx (F1 Liquid CDx) |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Foundation Medicine Inc. 150 Second Street Cambridge, MA 02141 |
PMA Number | P190032 |
Supplement Number | S005 |
Date Received | 08/15/2022 |
Decision Date | 05/03/2023 |
Product Code |
PQP |
Docket Number | 23M-1887 |
Notice Date | 05/15/2023 |
Advisory Committee |
Pathology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to include a companion diagnostic indication for EGFR exon 20 insertions in patients with non-small cell lung cancer who may benefit from treatment with EXKIVITY® (mobocertinib). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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