|
Device | FoundationOne CDx |
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 | S032 |
Date Received | 03/01/2021 |
Decision Date | 05/06/2022 |
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 F1CDx Validation Protocol and Statistical Analysis Plan: NTRK Clinical Efficacy Post Approval Study for larotrectinib |