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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 CARTRIGE AND DIMENSION VISTA TPSA 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
Newark, DE 19714
PMA NumberP000021
Supplement NumberS027
Date Received06/04/2015
Decision Date12/15/2015
Product Code MTF 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-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 MODIFIED PROCESS OF MANUFACTURING THEPOLYPROPYLENE RESIN USED IN THE PRODUCTION OF DIMENSION HM REACTION VESSELS AND THE VISTA LOCI REACTION VESSELS.
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