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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.
 
DeviceIMMUNO 1 COMPLEXED PSA ASSAY
Generic NameANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP990055
Supplement NumberS005
Date Received03/28/2002
Decision Date09/04/2002
Product Code NAF 
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 LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE.
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