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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 Cit, UT 84108
PMA NumberP140020
Supplement NumberS002
Date Received07/22/2015
Decision Date07/26/2016
Product Code PJG 
Advisory Committee Pathology
Supplement TypeReal-Time Process
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 1) labeling changes to include results from additional non-clinical studies, and 2) a variant reclassification process.
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