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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVIDAS TOTAL PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP040008
Supplement NumberS005
Date Received02/06/2013
Decision Date03/08/2013
Withdrawal Date 10/11/2017
Product Code MTF 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY.
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