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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 TPSA Flex reagent cartridge (RF451)
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark, DE 19714
PMA NumberP000021
Supplement NumberS032
Date Received06/20/2017
Decision Date07/17/2017
Product Codes LTJ 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  
Add the Siemens facility located in Flanders, NJ as an internal supplier for the tested subassembly components for Dimension® EXL system.
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