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 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 (NBCA) LIQUID EMBOLIC SYSTEM
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nameartificial embolization device
ApplicantCORDIS NEUROVASCULAR
PMA NumberP990040
Supplement NumberS004
Date Received04/28/2006
Decision Date06/01/2006
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the product label regarding use of the product under high flow conditions, and with ratios of contrast reagent and nbca outside of those ratios tested in the clinical study.
-
-