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.
Move fmi manufacturing operations from its current site at elk grove village, illinois, usa to a facility in lincolnshire, illinois, usa. Fmi is the currently approved supplier for molded silicone parts that go into the finished assembly and packaging of implantable pulse generators (ipgs), leads, lead extensions, lead adapters, and lead accessories.
| Device | GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS |
| Classification Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | Abbott Medical |
| Date Received | 2019-07-01 |
| Decision Date | 2019-07-29 |
| PMA | P010032 |
| Supplement | S153 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 6901 Preston Road plano, TX 75024 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010032 | Original Filing | |
| S194 | 2022-09-29 | 30-day Notice |
| S193 | ||
| S192 | ||
| S191 | ||
| S190 | 2022-08-11 | 30-day Notice |
| S189 | ||
| S188 | 2022-06-02 | 30-day Notice |
| S187 | ||
| S186 | ||
| S185 | 2022-02-22 | 30-day Notice |
| S184 | 2022-01-18 | 30-day Notice |
| S183 | 2021-10-22 | Real-time Process |
| S182 | 2021-10-05 | 30-day Notice |
| S181 | 2021-10-01 | 30-day Notice |
| S180 | ||
| S179 | 2021-07-01 | 30-day Notice |
| S178 | ||
| S177 | 2021-06-15 | Special (immediate Track) |
| S176 | ||
| S175 | 2021-05-10 | 30-day Notice |
| S174 | 2021-03-25 | 30-day Notice |
| S173 | ||
| S172 | ||
| S171 | ||
| S170 | 2020-12-17 | 30-day Notice |
| S169 | ||
| S168 | ||
| S167 | 2020-07-27 | Real-time Process |
| S166 | ||
| S165 | ||
| S164 | 2020-05-07 | 30-day Notice |
| S163 | 2020-04-30 | 30-day Notice |
| S162 | ||
| S161 | 2020-04-06 | 30-day Notice |
| S160 | 2020-04-06 | 30-day Notice |
| S159 | 2020-02-03 | 30-day Notice |
| S158 | 2019-12-13 | 30-day Notice |
| S157 | ||
| S156 | ||
| S155 | 2019-10-21 | 30-day Notice |
| S154 | 2019-07-01 | Real-time Process |
| S153 | 2019-07-01 | 30-day Notice |
| S152 | 2019-06-17 | 30-day Notice |
| S151 | ||
| S150 | 2019-05-07 | Normal 180 Day Track No User Fee |
| S149 | ||
| S148 | 2019-01-23 | Real-time Process |
| S147 | 2018-12-26 | Real-time Process |
| S146 | 2018-12-17 | 30-day Notice |
| S145 | 2018-11-08 | 30-day Notice |
| S144 | 2018-10-19 | 30-day Notice |
| S143 | 2018-09-06 | 30-day Notice |
| S142 | ||
| S141 | 2018-02-13 | Normal 180 Day Track |
| S140 | 2017-12-18 | 30-day Notice |
| S139 | 2017-12-15 | 30-day Notice |
| S138 | 2017-11-16 | 30-day Notice |
| S137 | 2017-11-15 | Real-time Process |
| S136 | 2017-11-13 | 30-day Notice |
| S135 | 2017-09-12 | Normal 180 Day Track |
| S134 | 2017-09-11 | Real-time Process |
| S133 | 2017-08-10 | 30-day Notice |
| S132 | 2017-07-28 | Normal 180 Day Track No User Fee |
| S131 | ||
| S130 | 2017-06-26 | 30-day Notice |
| S129 | 2017-06-02 | 30-day Notice |
| S128 | 2017-05-23 | 30-day Notice |
| S127 | 2016-11-07 | Normal 180 Day Track |
| S126 | 2016-11-01 | 30-day Notice |
| S125 | 2016-10-24 | Normal 180 Day Track |
| S124 | 2016-10-11 | Real-time Process |
| S123 | ||
| S122 | 2016-07-11 | Real-time Process |
| S121 | ||
| S120 | 2016-06-22 | Real-time Process |
| S119 | 2016-06-13 | 30-day Notice |
| S118 | 2016-06-06 | Normal 180 Day Track |
| S117 | 2016-04-28 | 30-day Notice |
| S116 | 2016-03-30 | 30-day Notice |
| S115 | 2016-03-21 | Normal 180 Day Track |
| S114 | 2016-03-21 | 30-day Notice |
| S113 | 2016-02-02 | 30-day Notice |
| S112 | 2016-01-27 | 30-day Notice |
| S111 | 2016-01-19 | 30-day Notice |
| S110 | 2015-12-23 | Real-time Process |
| S109 | 2015-12-11 | Normal 180 Day Track |
| S108 | 2015-12-08 | Real-time Process |
| S107 | 2015-11-09 | 30-day Notice |
| S106 | 2015-11-06 | 30-day Notice |
| S105 | 2015-10-08 | 30-day Notice |
| S104 | 2015-10-07 | 30-day Notice |
| S103 | 2015-10-06 | 30-day Notice |
| S102 | 2015-09-21 | Real-time Process |
| S101 | 2015-09-15 | 30-day Notice |
| S100 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S099 | 2015-08-14 | 30-day Notice |
| S098 | 2015-08-04 | Real-time Process |
| S097 | 2015-07-02 | Normal 180 Day Track |
| S096 | 2015-04-02 | Normal 180 Day Track |
| S095 | 2015-01-29 | 30-day Notice |
| S094 | 2014-12-24 | Real-time Process |
| S093 | 2014-12-24 | Normal 180 Day Track |
| S092 | 2014-12-19 | Normal 180 Day Track |
| S091 | 2014-12-15 | Normal 180 Day Track No User Fee |
| S090 | 2014-12-15 | Real-time Process |
| S089 | 2014-11-21 | 30-day Notice |
| S088 | 2014-11-20 | 30-day Notice |
| S087 | 2014-11-18 | Real-time Process |
| S086 | 2014-10-14 | 30-day Notice |
| S085 | 2014-09-29 | Normal 180 Day Track |
| S084 | 2014-09-08 | 30-day Notice |
| S083 | 2014-07-10 | Real-time Process |
| S082 | 2014-06-20 | 30-day Notice |
| S081 | 2014-06-11 | Real-time Process |
| S080 | 2014-05-29 | 30-day Notice |
| S079 | 2014-04-15 | Real-time Process |
| S078 | 2014-04-08 | Real-time Process |
| S077 | 2014-03-06 | 30-day Notice |
| S076 | 2014-01-10 | Real-time Process |
| S075 | 2014-01-03 | Normal 180 Day Track |
| S074 | 2013-12-23 | Real-time Process |
| S073 | 2013-07-29 | Normal 180 Day Track No User Fee |
| S072 | 2013-06-14 | 30-day Notice |
| S071 | 2013-05-20 | Real-time Process |
| S070 | 2013-03-11 | 30-day Notice |
| S069 | ||
| S068 | 2013-02-19 | Real-time Process |
| S067 | 2013-01-28 | Real-time Process |
| S066 | 2012-12-26 | Real-time Process |
| S065 | 2012-12-17 | 30-day Notice |
| S064 | 2012-11-07 | 30-day Notice |
| S063 | 2012-10-15 | Normal 180 Day Track |
| S062 | 2012-08-03 | 30-day Notice |
| S061 | 2012-07-30 | 135 Review Track For 30-day Notice |
| S060 | 2012-07-20 | 30-day Notice |
| S059 | 2012-07-17 | 135 Review Track For 30-day Notice |
| S058 | 2012-07-16 | Real-time Process |
| S057 | 2012-07-06 | Real-time Process |
| S056 | 2012-07-02 | 30-day Notice |
| S055 | 2012-06-06 | 135 Review Track For 30-day Notice |
| S054 | 2012-06-01 | Real-time Process |
| S053 | 2012-06-01 | Real-time Process |
| S052 | 2012-05-31 | 30-day Notice |
| S051 | 2012-04-19 | 30-day Notice |
| S050 | 2012-04-18 | 135 Review Track For 30-day Notice |
| S049 | 2012-03-27 | 30-day Notice |
| S048 | 2012-02-15 | Real-time Process |
| S047 | 2012-02-01 | 30-day Notice |
| S046 | ||
| S045 | 2011-12-21 | 30-day Notice |
| S044 | 2011-12-09 | 30-day Notice |
| S043 | 2011-10-04 | 30-day Notice |
| S042 | ||
| S041 | 2011-08-29 | Real-time Process |
| S040 | 2011-07-18 | Special (immediate Track) |
| S039 | 2011-06-20 | 135 Review Track For 30-day Notice |
| S038 | 2011-05-11 | 135 Review Track For 30-day Notice |
| S037 | 2010-12-29 | Real-time Process |
| S036 | 2010-11-23 | Real-time Process |
| S035 | 2010-10-21 | Special (immediate Track) |
| S034 | 2010-10-20 | Special (immediate Track) |
| S033 | ||
| S032 | 2009-07-15 | Real-time Process |
| S031 | 2009-07-01 | Normal 180 Day Track |
| S030 | ||
| S029 | 2009-04-02 | Real-time Process |
| S028 | 2009-01-08 | Normal 180 Day Track No User Fee |
| S027 | 2008-12-03 | 30-day Notice |
| S026 | 2008-06-10 | Real-time Process |
| S025 | 2008-04-11 | Real-time Process |
| S024 | 2008-01-22 | Special (immediate Track) |
| S023 | 2007-10-02 | Normal 180 Day Track |
| S022 | 2007-08-06 | Real-time Process |
| S021 | 2007-07-13 | Normal 180 Day Track |
| S020 | 2007-03-21 | Real-time Process |
| S019 | 2006-01-23 | Normal 180 Day Track |
| S018 | 2005-11-25 | Real-time Process |
| S017 | 2005-08-30 | Normal 180 Day Track |
| S016 | 2005-02-22 | Real-time Process |
| S015 | ||
| S014 | 2004-12-27 | Real-time Process |
| S013 | 2004-12-16 | Real-time Process |
| S012 | 2004-05-10 | Normal 180 Day Track |
| S011 | 2004-04-09 | Normal 180 Day Track No User Fee |
| S010 | 2004-03-24 | Real-time Process |
| S009 | 2003-11-12 | Real-time Process |
| S008 | 2003-05-28 | Real-time Process |
| S007 | 2003-01-23 | Normal 180 Day Track |
| S006 | 2002-11-04 | Real-time Process |
| S005 | 2002-10-24 | Real-time Process |
| S004 | ||
| S003 | 2002-07-02 | Real-time Process |
| S002 | 2002-05-14 | Real-time Process |
| S001 |