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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 NumberS027
Date Received09/20/2023
Decision Date11/07/2023
Product Code PLS 
Advisory Committee Pathology
Clinical TrialsNCT03615326
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an expansion of the current PD-L1 IHC 22C3 pharmDX indication to include a companion diagnostic (CDx) indication to use as an aid in identifying gastric or gastroesophageal junction (GEJ) adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).
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