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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 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 NumberS023
Date Received03/20/2012
Decision Date02/22/2013
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SOFTWARE REVISION THAT CHANGES THE OPERATING SYSTEM OF THE INSTRUMENT FROM THE CURRENT QNX OPERATING SYSTEM TO THE LINUX OPERATING SYSTEM AND ADDRESSES HARDWARE OBSOLESCENCE ISSUES.
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