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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 NameBAYER ADVIA IMS CPSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameimmunoassay for the quantitative measurement of complexed prostate-specific antigen (cpsa) in human serum
ApplicantBAYER HEALTHCARE, LLC
PMA NumberP990055
Supplement NumberS007
Date Received07/17/2003
Decision Date09/02/2003
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications
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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