Approval for the duraseal xact sealant system. The device is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
Supplemental Filings
Supplement Number | Date | Supplement Type |
P080013 | | Original Filing |
S024 |
2022-09-07 |
30-day Notice |
S023 |
2021-10-18 |
30-day Notice |
S022 | | |
S021 |
2020-08-17 |
30-day Notice |
S020 |
2020-06-23 |
Special (immediate Track) |
S019 | | |
S018 |
2019-12-30 |
Normal 180 Day Track No User Fee |
S017 |
2019-06-11 |
30-day Notice |
S016 |
2018-10-29 |
30-day Notice |
S015 |
2017-11-30 |
Normal 180 Day Track No User Fee |
S014 |
2017-07-28 |
Normal 180 Day Track No User Fee |
S013 |
2016-04-18 |
Real-time Process |
S012 | | |
S011 |
2015-02-02 |
Normal 180 Day Track No User Fee |
S010 | | |
S009 |
2013-06-04 |
135 Review Track For 30-day Notice |
S008 |
2013-03-25 |
Normal 180 Day Track No User Fee |
S007 |
2011-07-20 |
Special (immediate Track) |
S006 |
2011-03-21 |
Normal 180 Day Track No User Fee |
S005 | | |
S004 |
2011-03-02 |
Normal 180 Day Track No User Fee |
S003 |
2010-01-20 |
Normal 180 Day Track |
S002 |
2009-10-14 |
Real-time Process |
S001 |
2009-10-06 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices