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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 PSA CATALOG # LKPS1,5)
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSiemens Healthcare Diagnostics, Inc.
Glyn Rhonwy, Llanberis
Gwynedd Ll55 4el LL554EL
PMA NumberP930027
Supplement NumberS003
Date Received02/20/1998
Decision Date05/08/1998
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding information on the percentage for each PSA range for healthy male subjects as one group in the expected value section.
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