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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.
 
DeviceELECSYS TOTAL PSA IMMUNOASSAY
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP990056
Supplement NumberS004
Date Received10/05/2006
Decision Date10/13/2006
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT WHICH INCLUDES MODIFICATION OF THE EQUIMOLARITY STATEMENT FOUND IN THE SUMMARY SECTION, ADDITION OF LOB/LOD INFORMATION AND MINOR EDITORIAL REVISIONS.
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