Nucleus 24 Cochlear Implant System

FDA Premarket Approval P970051 S207

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.

Pre-market Approval Supplement Details

Remote assist, a new software feature intended to enable clinicians to make select programming adjustments, enable processor settings, and provide counselling via a live video session with their cochlear implant patients

DeviceNucleus 24 Cochlear Implant System
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received2021-07-13
Decision Date2021-10-08
PMAP970051
SupplementS207
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111

Supplemental Filings

Supplement NumberDateSupplement Type
P970051Original Filing
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

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