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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 NumberS018
Date Received09/21/2018
Decision Date12/19/2018
Product Code PJG 
Advisory Committee Pathology
Clinical TrialsNCT01844986
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 BRACAnalysis CDx®, for gBRCA mutated ovarian cancer patients maintenance monotherapy with Lynparza® (olaparib).
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