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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 COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY
Generic NameANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP990055
Supplement NumberS010
Date Received03/06/2009
Decision Date12/03/2009
Product Code NAF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE.
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