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 and Atellica IM PSA
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: Siemens Healthcare Diagnostics; 333 Coney St.; East Walpole, MA 02032
• PMA Number: P950021
• Supplement Number: S020
• Date Received: 02/21/2020
• Decision Date: 03/19/2020
• Product Code: MTF
• 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  
Scale-up and implementation of a common mixing process for all kit bulk reagents.