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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 FREE PSA (FPSA) ASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP080008
Supplement NumberS001
Date Received01/09/2012
Decision Date02/08/2012
Withdrawal Date01/31/2014
Product Code MTG 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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