|
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 | S020 |
Date Received | 12/06/2019 |
Decision Date | 05/19/2020 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Clinical Trials | NCT02987543
|
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 to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib). |
Labeling | Labeling
|