• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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.
 
DeviceTRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
Applicant
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham, MA 02767-0350
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S019 
S020 S021 S022 
-
-