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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 ARCHITECT TOTAL PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500
PMA NumberP910007
Supplement NumberS007
Date Received12/05/2001
Decision Date02/02/2004
Product Codes JIS JJX LTJ MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ABBOTT ARCHITECT TOTAL PSA ASSAY. THE ARCHITECT TOTAL PSA ASSAY IS INDICATED: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
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