|
Device | TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM |
Generic Name | tissue adhesive for use in embolization of brain arteriovenous malformations |
Applicant | Cerenovus, Inc. 6303 Waterford District Drive, Suite 315 Miami, FL 33126 |
PMA Number | P990040 |
Supplement Number | S004 |
Date Received | 04/28/2006 |
Decision Date | 06/01/2006 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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. |