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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 Immunoassay; Atellica IM Prostate-Specific Antigen (PSA)
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP950021
Supplement NumberS030
Date Received06/16/2025
Decision Date07/16/2025
Product Code MTG 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of a particle size analyzer utilized for the in-process testing of paramagnetic particles.
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