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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABBOTT AXSYM/TOTAL PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameabbolabo
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS006
Date Received06/15/2001
Decision Date03/03/2004
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at abbott health products, inc. , barceloneta, puerto rico.
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