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: VIDAS TOTAL PSA (TPSA) ASSAY
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: bioMerieux, Inc.; 595 Anglum Rd.; Hazelwood, MO 63042
• PMA Number: P040008
• Supplement Number: S007
• Date Received: 08/15/2013
• Decision Date: 09/12/2013
• Withdrawal Date: 10/11/2017
• 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  
REVIEW OF BIOMÉRIEUX¿S EXPANSION TO THE MANUFACTURING FACILITY IN MARCY L¿ETOILE (FRANCE).