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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 NumberS020
Date Received05/04/2011
Decision Date07/22/2011
Product Code MTG 
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 FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE.
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