This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | VNS Therapy System |
| Generic Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Applicant | LivaNova USA, Inc.100 Cyberonics Blvd.houston, TX 77058 PMA NumberP970003 Supplement NumberS237 Date Received12/19/2022 Decision Date01/18/2023 Product Codes LYJ MUZ Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-19 |
| Decision Date | 2023-01-18 |
| PMA | P970003 |
| Supplement | S237 |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LivaNova USA, Inc. 100 Cyberonics Blvd. houston, TX 77058 PMA NumberP970003 Supplement NumberS237 Date Received12/19/2022 Decision Date01/18/2023 Product Codes LYJ MUZ Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Introduce A New Parallel-gap Welding System And Its Associated Parameter Changes Used In The Production Of The M303 And M304 Leads. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05425025750160 | P970003 | 016 |
| 05425025750245 | P970003 | 039 |
| 05425025750016 | P970003 | 040 |
| 05425025750092 | P970003 | 040 |
| 05425025750108 | P970003 | 040 |
| 05425025750023 | P970003 | 047 |
| 05425025750122 | P970003 | 064 |
| 05425025750115 | P970003 | 064 |
| 05425025750047 | P970003 | 076 |
| 05425025750030 | P970003 | 076 |
| 05425025750153 | P970003 | 100 |
| 05425025750139 | P970003 | 100 |
| 05425025750054 | P970003 | 119 |
| 05425025750184 | P970003 | 148 |
| 05425025750191 | P970003 | 148 |
| 05425025750214 | P970003 | 154 |
| 05425025750382 | P970003 | 154 |
| 05425025750368 | P970003 | 173 |
| 05425025750061 | P970003 | 173 |
| 05425025750375 | P970003 | 183 |
| 05425025750405 | P970003 | 210 |
| 05425025750177 | P970003 | 210 |
| 05425025750399 | P970003 | 211 |
| 05425025750481 | P970003 | 215 |
| 05425025750429 | P970003 | 218 |
| 05425025750511 | P970003 | 225 |
| 05425025750504 | P970003 | 226 |
| 05425025750443 | P970003 | 226 |
| 05425025750528 | P970003 | 231 |
| 05425025750535 | P970003 | 234 |
| 05425025750634 | P970003 | 241 |