|
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 | S046 |
Date Received | 06/09/2023 |
Decision Date | 08/10/2023 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to labeling including updates to the Technical Information document for FICDx. |