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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 1000 FREE PSA AND IMMULITE 2000 FREE PSA
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 NumberS006
Date Received08/16/2011
Decision Date09/12/2011
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  
PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
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