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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.
 
DeviceTruSight Oncology Comprehensive
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantIllumina, Inc.
5200 Illumina Way
San Diego, CA 92122
PMA NumberP230011
Supplement NumberS007
Date Received03/27/2026
Decision Date04/23/2026
Product Code PQP 
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  
Labeling changes updating troubleshooting instructions.
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