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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.
 
DeviceBRACAnalysis CDx®
Generic NameCancer-related germline gene mutation detection system
ApplicantMYRIAD GENETIC LABORATORIES
320 Wakara Way
Salt Lake City, UT 84108
PMA NumberP140020
Supplement NumberS025
Date Received10/18/2022
Decision Date11/16/2022
Product Code PJG 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the removal of the companion diagnostic indication for BRACAnalysis CDx to identify patients with ovarian, fallopian tube, or primary peritoneal cancer with homologous recombination deficiency (HRD) positive status for treatment with Lynparza® (olaparib) and Rubraca® (rucaparib).
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