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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 NumberS004
Date Received11/25/2015
Decision Date12/22/2015
Product Code PJG 
Advisory Committee Pathology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO THE LABORATORY SPACE LAYOUT.
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