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 an alternate supplier of a manufacturing part.
Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Classification Name | Implant, Cochlear |
Generic Name | Implant, Cochlear |
Applicant | Cochlear Americas |
Date Received | 2013-10-22 |
Decision Date | 2014-03-05 |
PMA | P970051 |
Supplement | S113 |
Product Code | MCM |
Advisory Committee | Ear Nose & Throat |
Supplement Type | 135 Review Track For 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 |