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(SP142) CDX ASSAY
• Generic Name: Immunohistochemistry assay, antibody, programmed death-ligand 1
• Applicant: Ventana Medical Systems, Inc.; 1910 E. Innovation Park Dr.; Tucson, AZ 85755
• PMA Number: P160002
• Supplement Number: S001
• Date Received: 09/01/2016
• Decision Date: 12/21/2016
• Product Code: PLS
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the updated product labels and associated data.