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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 NameDIMENSION FPSA FLEX REAGENT
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nameprostate specific antigen (psa) for detection and management of prostate cancers
ApplicantSIEMENS CORP.
PMA NumberP020027
Supplement NumberS008
Date Received03/03/2008
Decision Date03/14/2008
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
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.
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