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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 CATRIDGE
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
ApplicantDADE BEHRING, INC.
PMA NumberP020027
Supplement NumberS005
Date Received12/06/2006
Decision Date01/04/2007
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to revise the cuvette film manufacturing process.
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