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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) ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
bioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP040008
Supplement NumberS007
Date Received08/15/2013
Decision Date09/12/2013
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REVIEW OF BIOMÉRIEUX¿S EXPANSION TO THE MANUFACTURING FACILITY IN MARCY L¿ETOILE (FRANCE).
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