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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSIEMENS 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 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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