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.
Approval for two minor design changes to the esprit (ear level) speech processor: 1) the addition of a 47uf capacitor; and 2) the lowering of the crystal q with insertion of a low value resistor (r3-120). As stated in the submission and described in the telephone conference on july 22, 1998, these two changes have been tested and validated. With reference to item 1), this change would lower the total harmonic distoriton resulting in improved audio signal. In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.
| Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 1998-07-20 |
| Decision Date | 1998-07-22 |
| PMA | P970051 |
| Supplement | S002 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970051 | Original Filing | |
| S216 | 2022-11-21 | Normal 180 Day Track No User Fee |
| S215 | 2022-11-14 | 30-day Notice |
| S214 | 2022-09-07 | Real-time Process |
| S213 | 2022-07-11 | 30-day Notice |
| S212 | ||
| S211 | ||
| S210 | 2022-02-08 | Normal 180 Day Track No User Fee |
| S209 | 2022-02-01 | 30-day Notice |
| S208 | ||
| S207 | 2021-07-13 | Real-time Process |
| S206 | ||
| S205 | ||
| S204 | 2021-02-24 | 30-day Notice |
| S203 | ||
| S202 | 2020-11-18 | 30-day Notice |
| S201 | 2020-11-12 | 30-day Notice |
| S200 | ||
| S199 | 2020-07-15 | 30-day Notice |
| S198 | 2020-04-16 | Normal 180 Day Track No User Fee |
| S197 | ||
| S196 | 2020-02-21 | 30-day Notice |
| S195 | 2020-01-14 | Special (immediate Track) |
| S194 | 2019-11-13 | 30-day Notice |
| S193 | ||
| S192 | 2019-09-09 | 30-day Notice |
| S191 | ||
| S190 | ||
| S189 | 2019-07-31 | 30-day Notice |
| S188 | ||
| S187 | ||
| S186 | 2019-06-06 | 30-day Notice |
| S185 | ||
| S184 | 2019-01-30 | 30-day Notice |
| S183 | ||
| S182 | 2018-11-01 | Normal 180 Day Track |
| S181 | 2018-08-13 | 30-day Notice |
| S180 | 2018-06-11 | Special (immediate Track) |
| S179 | 2018-04-27 | Special (immediate Track) |
| S178 | 2018-04-13 | 30-day Notice |
| S177 | 2018-02-15 | 30-day Notice |
| S176 | 2018-02-02 | 30-day Notice |
| S175 | 2018-01-02 | 30-day Notice |
| S174 | 2018-01-02 | 30-day Notice |
| S173 | 2017-11-13 | Normal 180 Day Track |
| S172 | ||
| S171 | 2017-09-28 | 30-day Notice |
| S170 | 2017-08-25 | 135 Review Track For 30-day Notice |
| S169 | 2017-08-07 | 30-day Notice |
| S168 | 2017-07-26 | 30-day Notice |
| S167 | 2017-07-17 | 30-day Notice |
| S166 | 2017-06-21 | Real-time Process |
| S165 | 2017-06-07 | 30-day Notice |
| S164 | 2017-05-23 | Normal 180 Day Track |
| S163 | 2017-05-16 | 30-day Notice |
| S162 | 2017-04-24 | 30-day Notice |
| S161 | 2017-04-18 | Real-time Process |
| S160 | 2017-04-10 | 30-day Notice |
| S159 | 2017-03-23 | 30-day Notice |
| S158 | 2017-02-27 | 30-day Notice |
| S157 | 2017-02-09 | Special (immediate Track) |
| S156 | 2017-02-07 | 30-day Notice |
| S155 | 2016-12-21 | 30-day Notice |
| S154 | 2016-11-23 | 30-day Notice |
| S153 | 2016-11-23 | 30-day Notice |
| S152 | ||
| S151 | 2016-10-12 | Normal 180 Day Track |
| S150 | 2016-09-22 | 30-day Notice |
| S149 | 2016-07-25 | 30-day Notice |
| S148 | 2016-06-23 | 30-day Notice |
| S147 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S146 | 2016-05-27 | 30-day Notice |
| S145 | 2016-02-24 | 30-day Notice |
| S144 | 2016-02-24 | Normal 180 Day Track |
| S143 | 2016-02-08 | Normal 180 Day Track |
| S142 | 2016-01-06 | 30-day Notice |
| S141 | 2016-01-05 | 30-day Notice |
| S140 | 2015-12-23 | Normal 180 Day Track |
| S139 | 2015-12-17 | 30-day Notice |
| S138 | 2015-12-04 | 30-day Notice |
| S137 | 2015-11-23 | Normal 180 Day Track |
| S136 | 2015-10-23 | 30-day Notice |
| S135 | 2015-10-13 | 30-day Notice |
| S134 | 2015-09-14 | 30-day Notice |
| S133 | 2015-07-31 | Normal 180 Day Track |
| S132 | 2015-07-23 | Normal 180 Day Track No User Fee |
| S131 | 2015-05-18 | 135 Review Track For 30-day Notice |
| S130 | 2015-05-07 | 135 Review Track For 30-day Notice |
| S129 | 2015-03-23 | Real-time Process |
| S128 | 2015-02-13 | 30-day Notice |
| S127 | 2014-12-24 | 30-day Notice |
| S126 | 2014-11-14 | Normal 180 Day Track |
| S125 | 2014-11-12 | 30-day Notice |
| S124 | 2014-11-12 | 30-day Notice |
| S123 | 2014-10-02 | Normal 180 Day Track |
| S122 | 2014-07-23 | 30-day Notice |
| S121 | 2014-06-09 | Real-time Process |
| S120 | 2014-05-16 | 30-day Notice |
| S119 | 2014-04-17 | 30-day Notice |
| S118 | 2014-03-28 | 30-day Notice |
| S117 | ||
| S116 | 2014-01-27 | Normal 180 Day Track |
| S115 | 2014-01-22 | 30-day Notice |
| S114 | 2014-01-15 | Real-time Process |
| S113 | 2013-10-22 | 135 Review Track For 30-day Notice |
| S112 | 2013-09-26 | Real-time Process |
| S111 | 2013-07-29 | 30-day Notice |
| S110 | 2013-06-28 | Normal 180 Day Track |
| S109 | 2013-04-10 | 30-day Notice |
| S108 | 2013-04-04 | 135 Review Track For 30-day Notice |
| S107 | 2013-03-27 | 135 Review Track For 30-day Notice |
| S106 | 2013-02-25 | 30-day Notice |
| S105 | 2013-02-07 | 135 Review Track For 30-day Notice |
| S104 | 2013-01-16 | Normal 180 Day Track |
| S103 | 2012-12-24 | Real-time Process |
| S102 | ||
| S101 | 2012-11-15 | 135 Review Track For 30-day Notice |
| S100 | 2012-11-15 | 135 Review Track For 30-day Notice |
| S099 | ||
| S098 | 2012-10-23 | 30-day Notice |
| S097 | 2012-09-11 | Real-time Process |
| S096 | 2012-08-27 | Normal 180 Day Track |
| S095 | 2012-08-06 | 30-day Notice |
| S094 | 2012-08-02 | Normal 180 Day Track |
| S093 | 2012-07-31 | Real-time Process |
| S092 | 2012-07-27 | 30-day Notice |
| S091 | 2012-07-13 | Normal 180 Day Track |
| S090 | ||
| S089 | 2011-12-30 | Real-time Process |
| S088 | 2011-10-26 | Real-time Process |
| S087 | 2011-09-22 | Real-time Process |
| S086 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S085 | 2011-08-05 | Real-time Process |
| S084 | ||
| S083 | ||
| S082 | 2011-06-29 | 135 Review Track For 30-day Notice |
| S081 | ||
| S080 | 2011-06-27 | 30-day Notice |
| S079 | ||
| S078 | 2011-06-24 | 30-day Notice |
| S077 | 2011-05-19 | 30-day Notice |
| S076 | 2011-05-19 | 30-day Notice |
| S075 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S074 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S073 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S072 | ||
| S071 | 2011-05-16 | 30-day Notice |
| S070 | 2011-05-16 | 135 Review Track For 30-day Notice |
| S069 | 2011-04-06 | Real-time Process |
| S068 | 2011-03-10 | Special (immediate Track) |
| S067 | 2011-02-03 | 30-day Notice |
| S066 | ||
| S065 | 2010-11-19 | 30-day Notice |
| S064 | 2010-10-01 | Normal 180 Day Track |
| S063 | 2010-09-27 | Real-time Process |
| S062 | 2009-12-23 | Real-time Process |
| S061 | ||
| S060 | 2009-12-09 | 135 Review Track For 30-day Notice |
| S059 | 2009-11-09 | 135 Review Track For 30-day Notice |
| S058 | 2009-11-02 | 30-day Notice |
| S057 | 2009-10-26 | 135 Review Track For 30-day Notice |
| S056 | ||
| S055 | 2009-10-13 | Special (immediate Track) |
| S054 | 2009-10-05 | 135 Review Track For 30-day Notice |
| S053 | 2009-09-25 | Normal 180 Day Track |
| S052 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S051 | 2009-06-11 | 30-day Notice |
| S050 | 2009-05-20 | Real-time Process |
| S049 | 2008-12-19 | Normal 180 Day Track |
| S048 | 2008-11-25 | Normal 180 Day Track |
| S047 | 2008-08-08 | 30-day Notice |
| S046 | 2008-07-25 | 30-day Notice |
| S045 | 2007-10-09 | Real-time Process |
| S044 | 2007-08-24 | 30-day Notice |
| S043 | 2007-08-24 | 30-day Notice |
| S042 | 2007-08-24 | 30-day Notice |
| S041 | 2007-08-24 | 30-day Notice |
| S040 | ||
| S039 | 2006-09-05 | 30-day Notice |
| S038 | 2006-04-21 | Real-time Process |
| S037 | 2006-04-13 | Real-time Process |
| S036 | 2006-01-24 | 30-day Notice |
| S035 | 2005-12-20 | Real-time Process |
| S034 | 2005-09-23 | Real-time Process |
| S033 | ||
| S032 | ||
| S031 | 2005-03-15 | Real-time Process |
| S030 | 2005-03-09 | 30-day Notice |
| S029 | 2004-09-17 | Normal 180 Day Track |
| S028 | 2004-07-01 | Normal 180 Day Track |
| S027 | 2003-10-06 | Real-time Process |
| S026 | 2003-09-04 | Real-time Process |
| S025 | 2003-08-13 | Normal 180 Day Track No User Fee |
| S024 | 2002-12-06 | Normal 180 Day Track |
| S023 | 2002-10-31 | Normal 180 Day Track |
| S022 | 2002-08-28 | Special (immediate Track) |
| S021 | 2002-07-16 | Normal 180 Day Track |
| S020 | 2002-06-13 | Real-time Process |
| S019 | 2001-10-23 | Normal 180 Day Track |
| S018 | 2001-07-23 | Normal 180 Day Track |
| S017 | 2001-06-22 | Normal 180 Day Track |
| S016 | 2001-04-19 | Normal 180 Day Track |
| S015 | 2001-03-19 | Normal 180 Day Track |
| S014 | 2001-01-16 | Real-time Process |
| S013 | 2000-12-29 | Normal 180 Day Track |
| S012 | 2000-11-29 | Normal 180 Day Track |
| S011 | 2000-07-21 | Normal 180 Day Track |
| S010 | 2000-02-23 | Normal 180 Day Track |
| S009 | 1999-12-17 | Real-time Process |
| S008 | 1999-09-20 | Normal 180 Day Track |
| S007 | 1999-08-13 | Real-time Process |
| S006 | 1999-04-15 | 30-day Notice |
| S005 | 1999-03-26 | Real-time Process |
| S004 | 1999-01-08 | Normal 180 Day Track |
| S003 | 1998-08-17 | Normal 180 Day Track |
| S002 | 1998-07-20 | Real-time Process |
| S001 | 1998-07-16 | Normal 180 Day Track |