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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.
 
DeviceIMMULITE 2000 Prostate-Specific Antigen (PSA)
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics, Inc.
Glyn Rhonwy, Llanberis
Gwynedd Ll55 4el LL554EL
PMA NumberP930027
Supplement NumberS034
Date Received12/20/2024
Decision Date01/15/2025
Product Code MTF 
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 move of critical raw material operations of an internal supplier in-house to an internal company site
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