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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.
 
DevicePSA IMMULITE ASSAY
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics, Inc.
Glyn Rhonwy, Llanberis
Gwynedd Ll55 4el LL554EL
PMA NumberP930027
Supplement NumberS012
Date Received08/08/2011
Decision Date09/07/2011
Product Code MTF 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE. THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE. FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.
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