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 | Nucleus 24 Cochlear Implant System |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS216 Date Received11/21/2022 Decision Date12/15/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-11-21 |
| Decision Date | 2022-12-15 |
| PMA | P970051 |
| Supplement | S216 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 PMA NumberP970051 Supplement NumberS216 Date Received11/21/2022 Decision Date12/15/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) Supplement, Which Requested Approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P970051/S205. |
| 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 |