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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
Applicant
Ventana Medical Systems, Inc.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP160046
Supplement NumberS010
Date Received06/14/2021
Decision Date10/15/2021
Product Code PLS 
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the VENTANA PD-L1 (SP263) Assay as a CDx for identifying patients with NSCLC tumors with PD-L1 status of >= 1% TC who may benefit from treatment with TECENTRIQ.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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