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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 DRIVE
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP000021
Supplement NumberS018
Date Received08/19/2010
Decision Date03/11/2011
Product Code MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES (VERSION 3.1.1. TO 3.3.) AND ASSOCIATED HARDWARE CHANGES TO THE DIMENSION VISTA SYSTEM.
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