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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 NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP000021
Supplement NumberS003
Date Received12/17/2003
Decision Date12/30/2003
Product Code LTJ 
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 OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX ANALYZER. THE DEVICE WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR: THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
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