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 ALK (D5F3) CDx Assay
• Generic Name: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
• Applicant: Ventana Medical Systems, Inc.; 1910 E. Innovation Park Dr.; Tucson, AZ 85755
• PMA Number: P140025
• Supplement Number: S021
• Date Received: 08/01/2023
• Decision Date: 08/29/2023
• Product Code: PKW
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of two contract manufacturers as approved suppliers of parts/components.