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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
ApplicantCerenovus, Inc.
6303 Waterford District Drive, Suite 315
Miami, FL 33126
PMA NumberP990040
Date Received07/16/1999
Decision Date09/25/2000
Product Code KGG 
Docket Number 00M-1569
Notice Date 10/20/2000
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM. THE DEVICE IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRESURGICAL DEVASCULARIZATION IS DESIRED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 
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