Approval for the neurocybernetic prothesis (ncp) system model 102r generator, human factors improvements to the model 102 generator and labeling changes to the model 302 lead which are indicated for use as an adjunctive therapy in reducing the frequency of seizures that are refractory to antiepileptic medications.
| 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 |