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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.
 
DeviceDIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
po box 6101
newark, DE 19714-6101
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 - manufacturer/sterilizer/packager/supplier
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 siemenshealthcare diagnostics, newark, delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
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