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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 NumberS007
Date Received09/21/2017
Decision Date11/20/2017
Product Code PLS 
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approved for labeling changes to include results from additional non-clinical studies.
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