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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 EAST INNOVATION PARK DR.
TUCSON, AZ 85755
PMA NumberP160002
Supplement NumberS007
Date Received06/18/2018
Decision Date09/13/2018
Product Code PLS 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument.
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