|
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 | S012 |
Date Received | 10/21/2019 |
Decision Date | 11/06/2019 |
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 Approval for adding fixed text language to the first page of the patient report indicating for Microsatellite Instability (MSI) results, confirmatory testing using a validated orthogonal method should be performed. |