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 TOTAL PSA & ARCHITECT TOTAL PSA
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Abbott Park, IL 60064
• PMA Number: P910007
• Supplement Number: S031
• Date Received: 09/07/2011
• Decision Date: 09/13/2011
• Product Code: MTF
• Advisory Committee: Immunology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.