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.
Change in biocompatibility information for the coil spacer (material specification change).
| Device | NUCLEUS COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 2007-08-24 |
| Decision Date | 2007-09-21 |
| PMA | P970051 |
| Supplement | S041 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |