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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 VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP000021
Supplement NumberS020
Date Received06/30/2011
Decision Date11/23/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the dimension vista tpsa flex reagent cartridge for use on the dimension vista 500 system.
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