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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.
 
DeviceFPSA IMMULITE ASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSiemens Medical Solutions Diagnostics Limited
Glyn Rhonwy Llanberis
Caernarfon
Gwynedd Ll55 4EL
PMA NumberP060005
Supplement NumberS005
Date Received08/08/2011
Decision Date09/07/2011
Product Code MTG 
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 CHEMILUSMINESCENT 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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