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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 NumberS002
Date Received02/07/2025
Decision Date09/02/2026
Product Code PQP 
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 AuthorizedYes
Approval Order Statement  
Approval for a Pre-specified Change Control Plan (PCCP) to modify the use of the device at a single laboratory to multiple laboratories
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