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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.
 
DeviceTPSA FLEX REAGENT
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 NumberS012
Date Received03/03/2008
Decision Date03/14/2008
Product Code MTF 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE PRODUCT INSTRUCTIONS FOR USE: 1) ADD A NEW SECTION TITLED RISK AND SAFETY TO PROVIDE ADDITIONAL SAFETY INFORMATION ABOUT THE PRESERVATIVES PRESENT IN SOME OF THE PRODUCT REAGENTS; 2) ADD INFORMATION UNDER THE SECTION TITLED PRECAUTIONS ON THE PRESENCE OF SODIUM AZIDE, ALONG WITH HAZARD AND DISPOSAL INFORMATION; AND 3) PROVIDE FOR REFERENCE ONLY ADDITIONAL UFU CHANGES BEING IMPLEMENTED CONCURRENTLY WITH THE SAFETY INFORMATION.
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