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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 CARTRIDGE
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP000021
Supplement NumberS018
Date Received08/19/2010
Decision Date03/11/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes (version 3. 1. 1. To 3. 3. ) and associated hardware changes to the dimension vista system.
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