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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 NameABBOTT IMX PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS004
Date Received11/02/1994
Decision Date08/07/1997
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 97M-0501
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new intended use and is indicated for the quantitative measurement of prostate specific antigen (psa) in: 1) human serum as an adjunctive test used as an aid in the management of prostate cancer patients; 2) human serum 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 diagnosis of cancer.
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