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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.
 
DeviceIMMULITE/IMMULITE 2000 PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
GLYN RHONWY, LLANBERIS
GWYNEDD LL55 4EL LL554
PMA NumberP930027
Supplement NumberS011
Date Received02/18/2011
Decision Date04/26/2011
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 INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
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