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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.
 
DeviceMyChoice CDx
Generic NameCancer-related germline gene mutation detection system
ApplicantMyriad Genetic Laboratories, Inc.
320 Wankara Way
Salt Lake City, UT 84108
PMA NumberP190014
Supplement NumberS009
Date Received04/22/2024
Decision Date08/29/2024
Product Code PJG 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for reagent expiration date extension of Capture Probes and Index Adapters
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