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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP990040
Date Received07/16/1999
Decision Date09/25/2000
Product Code
KGG[ Registered Establishments with KGG ]
Docket Number 00M-1569
Notice Date 10/20/2000
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 
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