Approval for updates to the model1000 sentiva generator, model2000 programming wand, and model3000 programmer; the updates are referred to as version 1. 5. These changes spanned new outer packaging for leads, generators, and accessory packs, model1000 generator firmware corrections, model1000 heart rate sensing requirement updates, model2000 wand firmware corrections, model2000 wand label cover addition, and model3000 programmer software enhancements and corrections.
| Device | VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer |
| Classification Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Generic Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Applicant | LivaNova USA, Inc. |
| Date Received | 2018-04-30 |
| Decision Date | 2018-07-27 |
| PMA | P970003 |
| Supplement | S218 |
| Product Code | LYJ |
| Advisory Committee | Neurology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LivaNova USA, Inc. 100 Cyberonics Blvd. houston, TX 77058 |
| Supplement Number | Date | Supplement Type |
|---|
| P970003 | | Original Filing |
| S237 |
2022-12-19 |
30-day Notice |
| S236 |
2022-04-11 |
Real-time Process |
| S235 |
2022-02-22 |
30-day Notice |
| S234 |
2020-11-12 |
Real-time Process |
| S233 | | |
| S232 |
2020-02-28 |
30-day Notice |
| S231 | | |
| S230 |
2019-12-06 |
30-day Notice |
| S229 |
2019-10-15 |
Real-time Process |
| S228 | | |
| S227 |
2019-09-26 |
30-day Notice |
| S226 |
2019-06-10 |
Real-time Process |
| S225 | | |
| S224 |
2019-04-24 |
30-day Notice |
| S223 |
2019-02-04 |
30-day Notice |
| S222 |
2019-01-15 |
Special (immediate Track) |
| S221 |
2018-12-27 |
Real-time Process |
| S220 | | |
| S219 |
2018-12-17 |
135 Review Track For 30-day Notice |
| S218 |
2018-04-30 |
Real-time Process |
| S217 | | |
| S216 |
2017-12-26 |
30-day Notice |
| S215 |
2017-12-04 |
Real-time Process |
| S214 |
2017-11-20 |
30-day Notice |
| S213 |
2017-07-19 |
30-day Notice |
| S212 | | |
| S211 |
2017-05-02 |
Normal 180 Day Track |
| S210 |
2017-04-03 |
Normal 180 Day Track |
| S209 |
2017-01-24 |
30-day Notice |
| S208 |
2016-12-19 |
30-day Notice |
| S207 |
2016-11-17 |
Panel Track |
| S206 |
2016-11-07 |
30-day Notice |
| S205 |
2016-11-04 |
Normal 180 Day Track |
| S204 |
2016-08-11 |
30-day Notice |
| S203 |
2016-07-15 |
30-day Notice |
| S202 |
2016-07-13 |
Special (immediate Track) |
| S201 |
2016-07-01 |
30-day Notice |
| S200 |
2016-05-23 |
Normal 180 Day Track No User Fee |
| S199 |
2016-05-09 |
30-day Notice |
| S198 |
2016-05-06 |
Normal 180 Day Track No User Fee |
| S197 |
2016-05-03 |
Normal 180 Day Track |
| S196 |
2016-04-18 |
Real-time Process |
| S195 |
2016-03-11 |
Normal 180 Day Track No User Fee |
| S194 |
2016-02-24 |
30-day Notice |
| S193 |
2016-02-23 |
30-day Notice |
| S192 |
2016-02-22 |
30-day Notice |
| S191 |
2016-02-17 |
30-day Notice |
| S190 |
2016-02-04 |
Real-time Process |
| S189 |
2016-01-29 |
Special (immediate Track) |
| S188 |
2015-11-24 |
Real-time Process |
| S187 |
2015-10-27 |
30-day Notice |
| S186 |
2015-10-09 |
30-day Notice |
| S185 |
2015-08-31 |
30-day Notice |
| S184 |
2015-07-29 |
30-day Notice |
| S183 |
2015-07-29 |
Real-time Process |
| S182 |
2015-07-01 |
Normal 180 Day Track |
| S181 |
2015-06-22 |
30-day Notice |
| S180 |
2015-06-08 |
30-day Notice |
| S179 |
2015-05-26 |
Real-time Process |
| S178 |
2015-03-23 |
30-day Notice |
| S177 |
2015-03-12 |
30-day Notice |
| S176 |
2014-12-09 |
Real-time Process |
| S175 |
2014-11-17 |
30-day Notice |
| S174 |
2014-11-17 |
Normal 180 Day Track No User Fee |
| S173 |
2014-10-23 |
Normal 180 Day Track |
| S172 |
2014-06-19 |
30-day Notice |
| S171 | | |
| S170 |
2014-04-28 |
Normal 180 Day Track No User Fee |
| S169 |
2014-04-04 |
Real-time Process |
| S168 |
2014-02-26 |
30-day Notice |
| S167 |
2013-12-03 |
30-day Notice |
| S166 |
2013-11-01 |
Normal 180 Day Track |
| S165 |
2013-08-12 |
30-day Notice |
| S164 |
2013-06-26 |
Real-time Process |
| S163 |
2013-04-23 |
30-day Notice |
| S162 |
2013-04-22 |
Real-time Process |
| S161 |
2013-04-05 |
30-day Notice |
| S160 |
2013-03-14 |
30-day Notice |
| S159 |
2013-03-11 |
30-day Notice |
| S158 |
2013-02-01 |
Real-time Process |
| S157 |
2013-01-24 |
Real-time Process |
| S156 |
2013-01-17 |
30-day Notice |
| S155 |
2012-11-19 |
135 Review Track For 30-day Notice |
| S154 |
2012-11-06 |
Real-time Process |
| S153 |
2012-10-01 |
30-day Notice |
| S152 |
2012-08-17 |
30-day Notice |
| S151 |
2012-08-07 |
30-day Notice |
| S150 |
2012-07-02 |
30-day Notice |
| S149 |
2012-06-06 |
30-day Notice |
| S148 |
2012-05-24 |
Real-time Process |
| S147 |
2012-03-14 |
30-day Notice |
| S146 |
2012-03-08 |
Normal 180 Day Track No User Fee |
| S145 |
2012-01-13 |
30-day Notice |
| S144 |
2012-01-06 |
30-day Notice |
| S143 |
2011-12-19 |
30-day Notice |
| S142 |
2011-12-02 |
30-day Notice |
| S141 |
2011-11-03 |
30-day Notice |
| S140 |
2011-10-21 |
Real-time Process |
| S139 |
2011-10-11 |
30-day Notice |
| S138 |
2011-09-30 |
30-day Notice |
| S137 |
2011-09-21 |
30-day Notice |
| S136 |
2011-09-20 |
30-day Notice |
| S135 |
2011-09-01 |
Real-time Process |
| S134 |
2011-08-11 |
30-day Notice |
| S133 |
2011-08-01 |
30-day Notice |
| S132 |
2011-07-05 |
30-day Notice |
| S131 |
2011-07-12 |
30-day Notice |
| S130 |
2011-06-27 |
Real-time Process |
| S129 |
2011-06-20 |
30-day Notice |
| S128 |
2011-06-13 |
30-day Notice |
| S127 |
2011-05-04 |
30-day Notice |
| S126 |
2011-04-20 |
30-day Notice |
| S125 |
2011-03-31 |
30-day Notice |
| S124 |
2011-03-16 |
135 Review Track For 30-day Notice |
| S123 |
2011-02-25 |
30-day Notice |
| S122 |
2011-01-31 |
30-day Notice |
| S121 |
2011-01-27 |
30-day Notice |
| S120 |
2011-01-24 |
30-day Notice |
| S119 |
2010-11-22 |
Real-time Process |
| S118 |
2010-11-19 |
30-day Notice |
| S117 |
2010-11-12 |
Normal 180 Day Track No User Fee |
| S116 |
2010-09-27 |
Real-time Process |
| S115 |
2010-09-21 |
Real-time Process |
| S114 |
2010-09-13 |
30-day Notice |
| S113 |
2010-08-11 |
30-day Notice |
| S112 |
2010-07-22 |
Real-time Process |
| S111 |
2010-06-22 |
Normal 180 Day Track No User Fee |
| S110 |
2010-05-27 |
135 Review Track For 30-day Notice |
| S109 |
2010-04-19 |
Special (immediate Track) |
| S108 |
2009-11-09 |
Special (immediate Track) |
| S107 | | |
| S106 |
2009-02-05 |
Normal 180 Day Track No User Fee |
| S105 |
2009-01-26 |
30-day Notice |
| S104 |
2008-11-26 |
Normal 180 Day Track No User Fee |
| S103 |
2008-10-31 |
Real-time Process |
| S102 |
2008-10-01 |
Special (immediate Track) |
| S101 |
2008-09-29 |
30-day Notice |
| S100 |
2008-07-24 |
Real-time Process |
| S099 |
2008-05-27 |
135 Review Track For 30-day Notice |
| S098 |
2008-02-04 |
Real-time Process |
| S097 |
2008-02-01 |
30-day Notice |
| S096 |
2008-01-23 |
Special (immediate Track) |
| S095 |
2007-11-21 |
Special (immediate Track) |
| S094 |
2007-11-19 |
30-day Notice |
| S093 |
2007-11-23 |
Real-time Process |
| S092 |
2007-10-16 |
30-day Notice |
| S091 |
2007-09-27 |
Normal 180 Day Track No User Fee |
| S090 |
2007-09-24 |
Normal 180 Day Track No User Fee |
| S089 |
2007-09-10 |
Special (immediate Track) |
| S088 |
2007-08-24 |
30-day Notice |
| S087 |
2007-08-17 |
30-day Notice |
| S086 |
2007-08-02 |
Real-time Process |
| S085 |
2007-06-11 |
Normal 180 Day Track No User Fee |
| S084 |
2007-05-29 |
30-day Notice |
| S083 |
2007-05-24 |
Normal 180 Day Track No User Fee |
| S082 |
2007-05-18 |
Special (immediate Track) |
| S081 |
2007-04-30 |
Special (immediate Track) |
| S080 |
2007-04-13 |
30-day Notice |
| S079 |
2007-04-13 |
Real-time Process |
| S078 |
2007-03-27 |
Special (immediate Track) |
| S077 |
2007-03-15 |
Normal 180 Day Track No User Fee |
| S076 |
2007-01-22 |
Normal 180 Day Track |
| S075 |
2006-12-15 |
Normal 180 Day Track No User Fee |
| S074 |
2006-10-10 |
Special (immediate Track) |
| S073 |
2006-10-06 |
30-day Notice |
| S072 |
2006-10-06 |
30-day Notice |
| S071 |
2006-08-24 |
Real-time Process |
| S070 |
2006-07-17 |
Real-time Process |
| S069 |
2006-07-12 |
Normal 180 Day Track No User Fee |
| S068 |
2006-06-16 |
Normal 180 Day Track |
| S067 |
2006-05-26 |
30-day Notice |
| S066 |
2006-04-17 |
Real-time Process |
| S065 |
2006-03-01 |
Real-time Process |
| S064 |
2006-02-01 |
Real-time Process |
| S063 |
2006-01-27 |
Real-time Process |
| S062 |
2005-11-07 |
Real-time Process |
| S061 | | |
| S060 |
2005-08-31 |
Normal 180 Day Track No User Fee |
| S059 |
2005-08-12 |
Normal 180 Day Track No User Fee |
| S058 |
2005-07-20 |
Special (immediate Track) |
| S057 |
2005-03-30 |
Special (immediate Track) |
| S056 | | |
| S055 |
2004-11-08 |
Real-time Process |
| S054 |
2004-02-06 |
30-day Notice |
| S053 |
2004-02-02 |
30-day Notice |
| S052 |
2003-12-08 |
30-day Notice |
| S051 |
2004-02-24 |
Normal 180 Day Track |
| S050 |
2003-10-27 |
Panel Track |
| S049 |
2003-10-21 |
Special (immediate Track) |
| S048 |
2003-09-17 |
Special (immediate Track) |
| S047 |
2003-06-20 |
Real-time Process |
| S046 |
2002-11-29 |
Normal 180 Day Track |
| S045 |
2002-10-24 |
Real-time Process |
| S044 | | |
| S043 | | |
| S042 |
2002-05-01 |
Real-time Process |
| S041 |
2002-04-29 |
Real-time Process |
| S040 |
2002-04-19 |
Real-time Process |
| S039 |
2002-04-17 |
Real-time Process |
| S038 |
2002-02-08 |
Real-time Process |
| S037 |
2002-01-10 |
Real-time Process |
| S036 | | |
| S035 |
2001-08-27 |
Special (immediate Track) |
| S034 |
2001-05-21 |
Real-time Process |
| S033 |
2001-05-07 |
Special (immediate Track) |
| S032 |
2001-03-23 |
Normal 180 Day Track |
| S031 |
2001-03-19 |
Real-time Process |
| S030 |
2001-01-26 |
Real-time Process |
| S029 | | |
| S028 | | |
| S027 |
2000-08-07 |
30-day Notice |
| S026 |
2000-06-01 |
Real-time Process |
| S025 |
1999-12-27 |
Real-time Process |
| S024 |
1999-12-03 |
Special (immediate Track) |
| S023 | | |
| S022 |
1999-04-01 |
Real-time Process |
| S021 |
1999-03-19 |
30-day Notice |
| S020 |
1999-03-19 |
30-day Notice |
| S019 |
1999-03-19 |
30-day Notice |
| S018 |
1999-01-19 |
Real-time Process |
| S017 |
1999-01-04 |
30-day Notice |
| S016 |
1999-01-04 |
Real-time Process |
| S015 |
1998-12-28 |
Normal 180 Day Track |
| S014 |
1998-12-21 |
Special (immediate Track) |
| S013 |
1998-12-04 |
Real-time Process |
| S012 |
1998-11-17 |
Real-time Process |
| S011 |
1998-10-01 |
30-day Notice |
| S010 |
1998-09-14 |
30-day Notice |
| S009 |
1998-02-19 |
30-day Notice |
| S008 |
1998-02-19 |
30-day Notice |
| S007 | | |
| S006 | | |
| S005 |
1997-09-16 |
Real-time Process |
| S004 |
1997-09-18 |
Real-time Process |
| S003 |
1997-09-18 |
Normal 180 Day Track |
| S002 |
1997-09-04 |
Real-time Process |
| S001 |
1997-08-07 |
Normal 180 Day Track |