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. |
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Device | PD-L1 IHC 22C3 pharmDx |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Agilent Technologies, Inc. 5301 Stevens Creek Blvd Santa Clara, CA 95051 |
PMA Number | P150013 |
Supplement Number | S021 |
Date Received | 08/31/2020 |
Decision Date | 02/22/2021 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Clinical Trials | NCT03088540
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Supplement Type | Normal 180 Day 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 as a companion diagnostic device to detect PD-L1 protein (Tumor Proportion Score ?50%) in patients with non-small cell lung cancer (NSCLC) for treatment with LIBTAYO. |
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