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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
Applicant
Agilent Technologies, Inc.
5301 stevens creek blvd
santa clara, CA 95051
PMA NumberP150013
Supplement NumberS020
Date Received06/29/2020
Decision Date11/13/2020
Product Code PLS 
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the PD-L1 IHC 22C3 pharmDX for expanding the indications to include detection of PD-L1 protein in patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA. We are pleased to inform you that the PMA supplement is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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