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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
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 NumberS053
Date Received03/16/2020
Decision Date05/23/2020
Product Code MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the ARCHITECT i1000SR System.
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