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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 FPSA FLEX REAGENT CARTRIDGE
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive, p o box 6101
m/s 514
newark, DE 19714-6101
PMA NumberP020027
Supplement NumberS020
Date Received05/03/2013
Decision Date05/28/2013
Product Code
MTG[ Registered Establishments with MTG ]
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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