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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 RXL MAX 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 NumberS014
Date Received04/06/2009
Decision Date06/04/2009
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE USE OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEMS (AMAS) (ADVIA LABCELL AND ADVIA WORKCELL).
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