|
Device | FoundationOne 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 | P200006 |
Supplement Number | S001 |
Date Received | 03/23/2021 |
Decision Date | 02/03/2022 |
APCB Date
|
05/26/2023 |
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 Statistical Analysis Plan Expanded Validation Study for the Efficacy of Rucaparib in Ovarian Cancer based on F1L CDx. |