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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.
 
DeviceBAYER ADVIA IMS 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 NumberS007
Date Received07/16/2003
Decision Date09/02/2003
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF THE CPSA ASSAY TO THE BAYER ADVIA IMS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAYER ADVIA IMS CPSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER IN CONJUNCTION WITH DIGITAL RECTAL EXAM.
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