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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 TOTAL PSA AND AXSYM 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 NumberS036
Date Received11/13/2012
Decision Date12/11/2012
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
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