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.
| Device | TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM |
| Classification Name | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations |
| Generic Name | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations |
| Applicant | CODMAN & SHURTLEFF, INC. |
| Date Received | 2006-04-28 |
| Decision Date | 2006-06-01 |
| PMA | P990040 |
| Supplement | S004 |
| Product Code | KGG |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CODMAN & SHURTLEFF, INC. 325 Paramount Drive raynham, MA 02767-0350 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990040 | | Original Filing |
| S029 |
2019-02-19 |
Normal 180 Day Track |
| S028 |
2018-11-15 |
30-day Notice |
| S027 |
2018-11-02 |
Normal 180 Day Track No User Fee |
| S026 |
2018-05-29 |
30-day Notice |
| S025 |
2017-06-08 |
30-day Notice |
| S024 |
2017-01-31 |
Normal 180 Day Track |
| S023 |
2016-11-14 |
30-day Notice |
| S022 |
2016-04-18 |
Normal 180 Day Track |
| S021 |
2015-08-28 |
30-day Notice |
| S020 |
2015-02-18 |
Real-time Process |
| S019 |
2014-09-17 |
Real-time Process |
| S018 | | |
| S017 |
2013-09-16 |
135 Review Track For 30-day Notice |
| S016 |
2010-11-24 |
30-day Notice |
| S015 |
2010-11-08 |
Real-time Process |
| S014 |
2010-10-12 |
30-day Notice |
| S013 |
2010-08-18 |
135 Review Track For 30-day Notice |
| S012 |
2010-07-28 |
Real-time Process |
| S011 |
2010-05-10 |
30-day Notice |
| S010 |
2009-11-13 |
30-day Notice |
| S009 |
2009-08-31 |
Normal 180 Day Track No User Fee |
| S008 |
2009-03-13 |
30-day Notice |
| S007 |
2008-12-19 |
30-day Notice |
| S006 |
2007-11-01 |
30-day Notice |
| S005 |
2007-07-20 |
135 Review Track For 30-day Notice |
| S004 |
2006-04-28 |
Special (immediate Track) |
| S003 |
2006-02-09 |
30-day Notice |
| S002 |
2006-02-09 |
30-day Notice |
| S001 |
2001-03-01 |
Normal 180 Day Track |
NIH GUDID Devices