|
Device | BRACAnalysis CDx |
Generic Name | cancer-related germline gene mutation detection system |
Applicant |
MYRIAD GENETIC LABORATORIES |
320 wakara way |
salt lake city, UT 84108 |
|
PMA Number | P140020 |
Supplement Number | S016 |
Date Received | 06/29/2018 |
Decision Date | 10/16/2018 |
Product Code |
PJG
|
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 for extending the label claim of the BRACAnalysis CDx® to include treatment and maintenance indications for Rubraca® (rucaparib) in ovarian cancer patients. |