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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMX TACROLIMUS II
Generic Nametacrolimus
ApplicantABBOTT LABORATORIES
PMA NumberP970007
Supplement NumberS002
Date Received02/27/2001
Decision Date03/30/2001
Advisory Committee Toxicology
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the current labeling for the device per 21 cfr 814. 39(d)(2). The current package insert states "hematocrit values ranging from 25 to 45% resulted in less than 12% error in detecting tacrolimus. " the package insert will be modified to state "hematocrit interference was evaluated by spiking known amounts of tacrolimus into pooled, whold blood samples diluted with saline. Hematocrit values ranging from 25 to 45% resulted in less than 31% error in detecting tacrolimus.
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