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: PD-L1 IHC 28-8 PHARMDX
• Generic Name: Immunohistochemistry assay, antibody, programmed death-ligand 1
• Applicant: Dako North America, Inc.; 6392 Via Real; Carpinteria, CA 93013
• PMA Number: P150027
• Supplement Number: S003
• Date Received: 08/29/2016
• Decision Date: 02/24/2017
• APCB Date: 03/13/2017
• 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 labeling and associated data.