|
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 | S008 |
Date Received | 04/09/2019 |
Decision Date | 07/01/2019 |
Product Code |
PQP
|
Advisory Committee |
Pathology |
Supplement Type | normal 180 day 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 TAGRISSO (osimertinib) in non-small cell lung cancer patients with EGFR exon 19 deletions and EGFR exon 21 L858R alterations. |