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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameimmunoassay for the quantitative measurement of complexed prostate-specific antigen (cpsa) in human serum
ApplicantSIEMENS CORP.
PMA NumberP990055
Supplement NumberS010
Date Received03/12/2009
Decision Date12/03/2009
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change in antibody growth manufacturing process from ascites fluid to cell culture.
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