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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
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, IN 46250
PMA NumberP990056
Supplement NumberS021
Date Received04/04/2014
Decision Date06/12/2014
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
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