|
Device | FoundationOne CDx (F1CDx) |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Foundation Medicine, Inc. 150 Second Street, 1st Floor Cambridge, MA 02141 |
PMA Number | P170019 |
Supplement Number | S023 |
Date Received | 12/01/2020 |
Decision Date | 06/30/2021 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Expanding the indications for use to include a CDx indication for detecting ALK rearrangements in non-small cell lung cancer patients who may be candidates for brigatinib treatment. |