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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.
 
DeviceADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP950021
Supplement NumberS018
Date Received07/03/2019
Decision Date07/25/2019
Product Code MTG 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to improve the instructions for use with regards to the High-Dose Hook Effect claim for Prostate Specific Antigen (PSA) with the value obtained using complexed PSA high dose hook in order to enhance the safety of the ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA.
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