This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for myriad mychoice® cdx to expand labeling based on solo1 study for the treatment of the patients with brca mutated advanced ovarian cancer with lynparza (olaparib).
|Generic Name||Cancer-related Germline Gene Mutation Detection System|
|Applicant||Myriad Genetic Laboratories, Inc|
|Supplement Type||Normal 180 Day Track|
|Supplement Reason||Labeling Change - Indications/instructions/shelf Life/tradename|
|Applicant Address||Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108|
|Supplement Number||Date||Supplement Type|
|S004||2020-07-28||Normal 180 Day Track|
|S003||2020-02-11||Normal 180 Day Track|
|S001||2020-01-23||Normal 180 Day Track|