|
Device | FoundationOne CDx (F1CDx) |
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 | S013 |
Date Received | 10/31/2019 |
Decision Date | 04/17/2020 |
Product Code |
PQP
|
Docket Number | 20M-1300 |
Notice Date | 04/21/2020 |
Advisory Committee |
Pathology |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval order for extending the label claim to include an indication for PEMAZYRE(pemigatinib)in cholangiocarcinoma patients with FGFR2 fusions and select rearrangements. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|