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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 
Docket Number 20M-2201
Notice Date 11/19/2020
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 
Approval 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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