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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
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP990056
Supplement NumberS017
Date Received02/29/2012
Decision Date03/28/2012
Product Code MTF 
Advisory Committee Immunology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TRANSFER THE REWORK LOCATION FROM BUILDING R TO A CONNECTED BUILDING W2 ON THE INDIANAPOLIS CAMPUS FOR THE DEVICE.
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