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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 IMX TACROLIMUS II
Generic NameENZYME IMMUNOASSAY, TRACROLIMUS
Regulation Number862.1678
ApplicantAbbott Laboratories
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064
PMA NumberP970007
Supplement NumberS001
Date Received09/17/1999
Decision Date09/22/1999
Reclassified Date 10/16/2002
Product Code MLM 
Advisory Committee Toxicology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
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