Approval for the following labeling change to the individualization of treatment section of the model 100/101 and 102 physician's manuals "preclinical study, teratogenic effects; there are no adequate and well-controlled studies of vns in pregnant women. Reproduction studies have been performed using female rabbits stimulated with the commercially available vns therapy system at stimulation dose settings similar to those used for humans. These animal studies have revealed no evidence of impaired fertility or harm to the fetus due to vns therapy. Because animal reproduction studies are not always predictive of human response and animal studies cannot address developmental abnormalities, vns should be used during pregnancy only if clearly needed. Although the operating ranges of the vns therapy system and fetal monitors are dissimilar and no interaction would be expected, testing has not been performed. Therefore, the potential may exist for interaction between the vns therapy system and fetal monitoring systems. "
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 |