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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 device
Generic NameCancer-related germline gene mutation detection system
320 Wakara Way
Salt Lake City, UT 84108
PMA NumberP140020
Supplement NumberS015
Date Received04/09/2018
Decision Date10/16/2018
Product Code PJG 
Advisory Committee Pathology
Clinical TrialsNCT01945775
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 extending the label claim of the BRACAnalysis CDx to include an indication for TALZENNA (talazoparib) in breast cancer patients.