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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 (TPSA)
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP040008
Supplement NumberS002
Date Received01/09/2012
Decision Date02/08/2012
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 SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.
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