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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 NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr. P.O. Box 6101. M/S 514
Newark, DE 19714
PMA NumberP020027
Supplement NumberS039
Date Received11/18/2021
Decision Date12/20/2021
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  
Addition of an Alternate Supplier for the Lens and Mirror components used in Photometer Assembly on the Dimension Family of Instruments.
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