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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicemyChoice CDx
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantMyriad Genetic Laboratories, Inc
320 wankara way
salt lake city, UT 84108
PMA NumberP190014
Supplement NumberS003
Date Received02/11/2020
Decision Date05/08/2020
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT02477644
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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)".
LabelingLabeling
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