A change to the bha concentration specified for n-bca during manufacture, prior to the dry heat sterilization process.
| Device | TRUFILL n-Butyl Cyanoacrylate (n-BCA) 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 | 2019-02-19 |
| Decision Date | 2019-09-18 |
| PMA | P990040 |
| Supplement | S029 |
| Product Code | KGG |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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