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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.
 
DeviceADVIA CENTAUR CPSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameantigen(complexed),prostate specific,(cpsa)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, MA 02032-1516
PMA NumberP990055
Supplement NumberS013
Date Received08/06/2010
Decision Date08/30/2010
Product Code
NAF[ Registered Establishments with NAF ]
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 
IMPLEMENTATION OF AN AUTOMATED PROCESS FOR MAKING A COMPONENT THAT IS COMMON TO THE PSA AND CPSA ASSAYS.
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