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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 FREE PSA CALSET
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP000027
Supplement NumberS017
Date Received12/19/2012
Decision Date04/10/2013
Product Code MTG 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A TRANSFER FROM PACKAGING LINE 20 IN BUILDING 398, TO PACKAGING LINE 19 IN BUILDING 493 WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABEL SIZE, AND LABEL LAYOUT.
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