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: Elecsys total PSA, total PSA CalSet II
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: Roche Diagnostics Corp.; 9115 Hague Rd.; Indianapolis, IN 46250
• PMA Number: P990056
• Supplement Number: S024
• Date Received: 09/07/2016
• Decision Date: 03/02/2017
• Product Code: MTF
• Advisory Committee: Immunology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a modification to the proprietary device names.