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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.
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
PMA NumberP910007
Supplement NumberS009
Date Received01/31/2003
Decision Date02/02/2004
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the abbott imx total psa assay. The device, as modified, will be marketed under the trade name abbott imx total psa assay and is indicated as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer.