|
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 |
Clinical Trials | NCT01891344
|
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. |