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: ADVIA Centaur PSA Readypack Reagents
• Generic Name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
• Applicant: Siemens Healthcare Diagnostics; 333 Coney St.; East Walpole, MA 02032
• PMA Number: P950021
• Supplement Number: S023
• Date Received: 09/29/2020
• Decision Date: 10/27/2020
• Product Code: MTG
• Advisory Committee: Immunology
• 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  
Implementation of medical decision pools for use in the control system.