Premarket Approval (PMA)

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.

• Device: Ventana PD-L1 (SP263)
• Generic Name: Immunohistochemistry assay, antibody, programmed death-ligand 1
• Applicant: Ventana Medical Systems, Inc.; 1910 E. Innovation Park Dr.; Tucson, AZ 85755
• PMA Number: P160046
• Supplement Number: S004
• Date Received: 04/03/2018
• Decision Date: 06/01/2018
• Product Code: PLS
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for additional analytical validation data and associated updated product labeling.