|
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 | S019 |
Date Received | 07/02/2019 |
Decision Date | 12/27/2019 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Clinical Trials | NCT02184195
|
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 expansion of the indications for use as a companion diagnostic for LYNPARZA (olaparib) inpancreatic cancer patients |