|
Device | FoundationOne CDx (FICDx) |
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 | S038 |
Date Received | 08/29/2022 |
Decision Date | 09/27/2022 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approved removal of the companion diagnostic indication for FoundationOne® CDx (FICDx) to identify patients with ovarian cancer harboring BRCA1 or BRCA2 alterations for treatment with rucaparib. |