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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
ApplicantMyriad Genetic Laboratories, Inc.
320 Wankara Way
Salt Lake City, UT 84108
PMA NumberP190014
Supplement NumberS008
Date Received01/20/2023
Decision Date10/27/2023
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to replace the Illumina HiSeq 2500 Sequencer with the Illumina Next-generation Sequencer (NovaSeq 6000) for MyChoice CDx device.
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