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 PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
• Generic Name: Immunohistochemistry antibody assay, c-kit
• Regulation Number: 864.1860
• Applicant: Ventana Medical Systems, Inc.; 1910 E. Innovation Park Dr.; Tucson, AZ 85755
• PMA Number: P020055
• Supplement Number: S017
• Date Received: 08/26/2015
• Decision Date: 09/24/2015
• Product Code: NKF
• 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  
CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.