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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
Classification Namecancer-related germline gene mutation detection system
Generic Namecancer-related germline gene mutation detection system
Applicant
MYRIAD GENETIC LABORATORIES
320 wakara way
salt lake city, UT 84108
PMA NumberP140020
Supplement NumberS016
Date Received06/29/2018
Decision Date10/16/2018
Product Code
PJG[ Registered Establishments with PJG ]
Advisory Committee Pathology
Clinical Trials NCT01891344
NCT01968213
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the label claim of the BRACAnalysis CDx® to include treatment and maintenance indications for Rubraca® (rucaparib) in ovarian cancer patients.
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