Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
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 
-
-