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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 NumberS019
Date Received07/02/2019
Decision Date12/27/2019
Product Code PJG 
Advisory Committee Pathology
Clinical TrialsNCT02184195
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expansion of the indications for use as a companion diagnostic for LYNPARZA (olaparib) inpancreatic cancer patients
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