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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.
 
DeviceVENTANA PD-L1 (SP263) Assay
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP160046
Supplement NumberS013
Date Received04/21/2022
Decision Date03/01/2023
Product Code PLS 
Docket Number 23M-0905
Notice Date 03/16/2023
Advisory Committee Pathology
Clinical TrialsNCT03088540
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the VENTANA PD-L1 (SP263) Assay as a companion diagnostic for identifying patients with non-small cell lung carcinoma (NSCLC) with PD-L1 expression of >= 50% tumor cells (TC) for treatment with LIBTAYO.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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