|
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 | S050 |
Date Received | 11/03/2023 |
Decision Date | 12/01/2023 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the clinical protocol entitled FoundationOne®CDx Clinical Validation Protocol RET Fusions Clinical Efficacy Post-Approval Study for Selpercatinib |