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) 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: S024
• Date Received: 03/06/2024
• Decision Date: 04/01/2024
• Product Code: PLS
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for addition of raw material evaluation method to ensure quality of the incoming reagents