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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 NumberS026
Date Received06/12/2023
Decision Date07/05/2023
Product Code PLS 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate 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 updates to Instructions for Use and manufacturing quality control technical procedure intended to mitigate nonspecific nuclear staining in formalin-fixed, paraffin-embedded (FFPE) tumor specimens stained with the Negative Control Reagent (NCR) from PD-L1 IHC 22C3 pharmDx.
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