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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 Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
500 gbc drive
po box 6101
newark, DE 19714-6101
PMA NumberP000021
Supplement NumberS012
Date Received03/03/2008
Decision Date03/14/2008
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the product instructions for use: 1) add a new section titled risk and safety to provide additional safety information about the preservatives present in some of the product reagents; 2) add information under the section titled precautions on the presence of sodium azide, along with hazard and disposal information; and 3) provide for reference only additional ufu changes being implemented concurrently with the safety information.