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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 NameTRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nameartificial embolization device
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP990040
Supplement NumberS012
Date Received07/29/2010
Decision Date09/27/2010
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relabeling and repackaging the ethiodized oil component to meet the current codman specification.
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