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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.
 
DeviceARCHITECT FREE PSA
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2 DEPT 09VB
ABBOTT PARK, IL 60064-6070
PMA NumberP980007
Supplement NumberS024
Date Received11/23/2011
Decision Date12/21/2011
Product Code MTG 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.
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