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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.
 
DevicexT CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantTempus AI, Inc.
600 W Chicago Ave.
Suite #510
Chicago, IL 60654
PMA NumberP210011
Supplement NumberS004
Date Received06/30/2025
Decision Date05/28/2026
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternative method of germline subtraction and implementing an updated MSI caller in the bioinformatics pipeline.
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