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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 NameIMMUNO 1 COMPLEXED PSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
ApplicantBAYER HEALTHCARE, LLC
PMA NumberP990055
Supplement NumberS005
Date Received03/28/2002
Decision Date09/04/2002
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes. The labeling changes include the revision of literature cited in the summary and explanation section and the addition of summary data from a new clinical study. There is no change in the indication for use.
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