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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.
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
333 coney street
walpole, MA 02032-1516
PMA NumberP950021
Supplement NumberS001
Date Received12/22/1998
Decision Date06/25/1999
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 99M-2748
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Bayer Immuno 1(TM) PSA assay. This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling