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 include a companion diagnostic indication for homologous recombination deficiency (hrd) in ovarian cancer patients who may benefit from maintenance treatment with lynparza® (olaparib)"
|Generic Name||Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant 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|
|S003||2020-02-11||Normal 180 Day Track|
|S001||2020-01-23||Normal 180 Day Track|