Note: 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. |
|
Device | myChoice CDx |
Generic Name | next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant |
Myriad Genetic Laboratories, Inc |
320 wankara way |
salt lake city, UT 84108 |
|
PMA Number | P190014 |
Supplement Number | S003 |
Date Received | 02/11/2020 |
Decision Date | 05/08/2020 |
Product Code |
PQP
|
Advisory Committee |
Pathology |
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 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)". |
Labeling |
Labeling
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