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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
ApplicantMYRIAD GENETIC LABORATORIES
320 Wakara Way
Salt Lake City, UT 84108
PMA NumberP140020
Supplement NumberS027
Date Received01/27/2023
Decision Date04/26/2023
Advisory Committee Pathology
Clinical TrialsNCT01847274
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 the change of Zejula® (niraparib) indication from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations, who are or may become eligible for maintenance treatment with Zejula® (niraparib).
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