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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 NumberS033
Date Received09/29/2025
Decision Date02/10/2026
Product Code PLS 
Advisory Committee Pathology
Clinical TrialsNCT05116189
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 PD-L1 IHC 22C3 pharmDx for expanding the indications to include use as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) for treatment with KEYTRUDA® (pembrolizumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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