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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.
 
DeviceDimension FPSA Flex reagent cartridge
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr. P.O. Box 6101. M/S 514
Newark, DE 19714
PMA NumberP020027
Supplement NumberS042
Date Received04/23/2025
Decision Date05/22/2025
Product Codes MTF 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  
Transfer of Service Spare Parts Production to Contract Manufacturer.
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