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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 XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP950021
Supplement NumberS011
Date Received04/10/2009
Decision Date06/10/2009
Product Code MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR PSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP PSA ASSAY AND ISINDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.
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