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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 (LN 6C07)
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
PMA NumberP980007
Supplement NumberS040
Date Received07/16/2015
Decision Date08/13/2015
Product Code MTG 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
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