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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 (SP142) Assay
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, AZ 85755
PMA NumberP160002
Supplement NumberS012
Date Received01/21/2020
Decision Date05/18/2020
Product Code PLS 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the VENTANA PD-L1 (SP142) Assay as a companion diagnostic for identifying patients with non-small cell lung carcinoma (NSCLC) with PD-L1 expression in TC >= 50% or IC >= 10% for treatment with TECENTRIQ based upon the IMpower110 clinical study.
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