|Trade Name||ABBOTT IMX TOTAL PSA|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Generic Name||prostate-specific antigen (psa) for management of prostate cancers|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| 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.