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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
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP000021
Supplement NumberS025
Date Received05/03/2013
Decision Date05/28/2013
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the supplier for dextran t110 from sigma adrich fine chemicals (safc) to pharmacomos and to bring phthalocyanine manufacture in-house at the siemens healthcare diagnostics, newark, delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
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