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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.
 
DeviceVENTANA PD-L1 (SP142) Assay
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP160002
Supplement NumberS015
Date Received09/07/2021
Decision Date09/28/2021
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  
Approved for removal of the triple negative breast cancer (TNBC) indication from the device intended use statement and labeling.
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