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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.
 
DeviceABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
Abbott Laboratories
100 abbott park rd.
abbott park, IL 60064-3500
PMA NumberP910007
Supplement NumberS015
Date Received08/12/2005
Decision Date09/13/2005
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF A BIAS ANALYSIS STUDY TO THE REAGENT PACKAGE INSERTS.
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