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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-Ll (SP142) Assay
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantVentana Medical Systems, Inc.
1910 E Innovation Park Dr.
Tucso, AZ 85755
PMA NumberP160002
Supplement NumberS017
Date Received02/16/2022
Decision Date07/21/2022
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.
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