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: AXSYM FREE PSA (LN 3C20)
• Generic Name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Ap5n-2, Dept. 09vb; Abbott Park, IL 60064
• PMA Number: P980007
• Supplement Number: S012
• Date Received: 09/27/2010
• Decision Date: 10/20/2010
• 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  
MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.