Approval for labeling changes being made to the model 100 ncp pulse generator physician's manual, the model 300 ncp bipolar lead physician's manual, and the patient's manual for the ncp system.
Device | NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM |
Classification Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
Generic Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
Applicant | LivaNova USA, Inc. |
Date Received | 1998-12-21 |
Decision Date | 1999-01-20 |
PMA | P970003 |
Supplement | S014 |
Product Code | LYJ |
Advisory Committee | Neurology |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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 |