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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 VISTA 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 NumberS013
Date Received08/19/2010
Decision Date03/11/2011
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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