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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.
 
DevicePD-L1 IHC 22C3 pharmDx
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 stevens creek blvd
santa clara, CA 95051
PMA NumberP150013
Supplement NumberS022
Date Received11/16/2020
Decision Date01/31/2022
Product Code PLS 
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the final report for the External Reproducibility Study (Part B – Inter-Observer) using the PD-L1 IHC 22C3 pharmDx in esophogeal squamous cell carcinoma specimens and the proposed changes to the labeling to include the results of this study.
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