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.
Manufacturing change for the hifocus mid-scala electrode array.
| Device | HiResolution Bionic Ear System |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | ADVANCED BIONICS |
| Date Received | 2017-09-05 |
| Decision Date | 2017-10-05 |
| PMA | P960058 |
| Supplement | S123 |
| 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 | ADVANCED BIONICS 28515 Westinghouse Place valencia, CA 91355 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960058 | Original Filing | |
| S156 | 2022-08-12 | 30-day Notice |
| S155 | 2022-07-13 | 30-day Notice |
| S154 | 2021-12-17 | 30-day Notice |
| S153 | 2021-03-31 | 30-day Notice |
| S152 | 2021-03-26 | 30-day Notice |
| S151 | 2020-11-27 | 30-day Notice |
| S150 | 2020-06-25 | 30-day Notice |
| S149 | ||
| S148 | 2020-04-29 | 30-day Notice |
| S147 | 2019-12-18 | 30-day Notice |
| S146 | 2019-11-19 | 30-day Notice |
| S145 | ||
| S144 | ||
| S143 | 2019-09-25 | 30-day Notice |
| S142 | 2019-08-02 | 30-day Notice |
| S141 | 2019-07-26 | 30-day Notice |
| S140 | 2019-06-03 | 30-day Notice |
| S139 | 2019-05-06 | Real-time Process |
| S138 | 2019-02-27 | 30-day Notice |
| S137 | 2019-02-04 | 30-day Notice |
| S136 | 2019-01-29 | 30-day Notice |
| S135 | 2018-12-14 | 30-day Notice |
| S134 | 2018-12-13 | 30-day Notice |
| S133 | ||
| S132 | 2018-09-13 | Normal 180 Day Track |
| S131 | ||
| S130 | 2018-07-16 | 30-day Notice |
| S129 | 2018-03-12 | Normal 180 Day Track |
| S128 | 2018-02-13 | 30-day Notice |
| S127 | ||
| S126 | 2017-10-26 | 30-day Notice |
| S125 | 2017-09-29 | 30-day Notice |
| S124 | 2017-09-28 | 30-day Notice |
| S123 | 2017-09-05 | 30-day Notice |
| S122 | 2017-06-05 | Normal 180 Day Track |
| S121 | 2017-05-08 | Normal 180 Day Track |
| S120 | 2016-11-23 | Normal 180 Day Track |
| S119 | 2016-07-22 | Normal 180 Day Track |
| S118 | 2015-08-21 | 30-day Notice |
| S117 | 2015-08-03 | Normal 180 Day Track |
| S116 | 2015-07-13 | Normal 180 Day Track No User Fee |
| S115 | 2015-02-18 | Normal 180 Day Track |
| S114 | 2015-01-02 | Normal 180 Day Track |
| S113 | 2014-11-13 | 30-day Notice |
| S112 | 2014-11-28 | Normal 180 Day Track |
| S111 | 2014-09-15 | Normal 180 Day Track |
| S110 | ||
| S109 | 2014-04-21 | Normal 180 Day Track |
| S108 | 2014-02-14 | Normal 180 Day Track |
| S107 | 2014-01-16 | 30-day Notice |
| S106 | 2013-12-13 | Normal 180 Day Track |
| S105 | 2013-12-09 | 30-day Notice |
| S104 | 2013-08-19 | 30-day Notice |
| S103 | 2013-07-17 | 135 Review Track For 30-day Notice |
| S102 | 2013-02-04 | Normal 180 Day Track |
| S101 | 2012-11-19 | 135 Review Track For 30-day Notice |
| S100 | 2012-11-13 | Normal 180 Day Track |
| S099 | 2012-10-22 | Normal 180 Day Track |
| S098 | 2012-09-10 | Normal 180 Day Track |
| S097 | 2012-07-27 | 30-day Notice |
| S096 | 2012-04-11 | 135 Review Track For 30-day Notice |
| S095 | 2011-12-30 | Normal 180 Day Track No User Fee |
| S094 | 2011-11-02 | Normal 180 Day Track |
| S093 | 2011-10-21 | Normal 180 Day Track |
| S092 | 2011-10-03 | 30-day Notice |
| S091 | 2011-09-30 | Normal 180 Day Track |
| S090 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S089 | 2011-06-01 | Normal 180 Day Track |
| S088 | ||
| S087 | 2010-10-22 | Real-time Process |
| S086 | ||
| S085 | 2010-05-13 | Normal 180 Day Track |
| S084 | 2010-04-07 | 135 Review Track For 30-day Notice |
| S083 | ||
| S082 | 2009-08-28 | Normal 180 Day Track |
| S081 | 2009-05-13 | 30-day Notice |
| S080 | 2009-03-26 | Normal 180 Day Track |
| S079 | 2009-02-23 | Real-time Process |
| S078 | 2009-02-06 | 30-day Notice |
| S077 | ||
| S076 | 2008-12-01 | Normal 180 Day Track |
| S075 | 2008-11-18 | 135 Review Track For 30-day Notice |
| S074 | 2008-11-12 | 135 Review Track For 30-day Notice |
| S073 | 2008-11-10 | Special (immediate Track) |
| S072 | ||
| S071 | ||
| S070 | 2008-10-01 | 30-day Notice |
| S069 | ||
| S068 | ||
| S067 | ||
| S066 | 2008-06-02 | 135 Review Track For 30-day Notice |
| S065 | ||
| S064 | ||
| S063 | ||
| S062 | ||
| S061 | 2008-03-24 | Real-time Process |
| S060 | ||
| S059 | ||
| S058 | 2007-05-07 | Normal 180 Day Track |
| S057 | 2007-04-18 | 135 Review Track For 30-day Notice |
| S056 | ||
| S055 | 2006-10-17 | 135 Review Track For 30-day Notice |
| S054 | 2006-07-17 | Normal 180 Day Track No User Fee |
| S053 | 2006-03-08 | Special (immediate Track) |
| S052 | ||
| S051 | ||
| S050 | 2005-12-23 | 30-day Notice |
| S049 | 2005-12-12 | Normal 180 Day Track |
| S048 | 2005-11-07 | 30-day Notice |
| S047 | 2005-10-27 | Normal 180 Day Track |
| S046 | 2005-06-27 | Real-time Process |
| S045 | 2005-06-27 | Normal 180 Day Track |
| S044 | ||
| S043 | 2005-07-05 | Normal 180 Day Track |
| S042 | 2005-05-03 | Normal 180 Day Track No User Fee |
| S041 | ||
| S040 | 2004-12-14 | Normal 180 Day Track |
| S039 | ||
| S038 | 2004-07-28 | Normal 180 Day Track |
| S037 | 2004-05-10 | Special (immediate Track) |
| S036 | 2004-04-22 | Normal 180 Day Track |
| S035 | 2004-04-15 | 30-day Notice |
| S034 | 2004-03-03 | Normal 180 Day Track |
| S033 | 2004-02-09 | Real-time Process |
| S032 | 2003-12-09 | Real-time Process |
| S031 | 2003-05-23 | Real-time Process |
| S030 | 2003-03-18 | Normal 180 Day Track |
| S029 | 2003-01-13 | Normal 180 Day Track |
| S028 | 2002-11-01 | Normal 180 Day Track |
| S027 | 2002-10-25 | Real-time Process |
| S026 | 2002-10-25 | Real-time Process |
| S025 | 2002-09-19 | Real-time Process |
| S024 | 2002-09-16 | Real-time Process |
| S023 | 2002-07-29 | Normal 180 Day Track |
| S022 | 2002-05-28 | Real-time Process |
| S021 | 2002-05-28 | Real-time Process |
| S020 | 2002-04-12 | Real-time Process |
| S019 | ||
| S018 | ||
| S017 | ||
| S016 | ||
| S015 | 2000-11-16 | Normal 180 Day Track |
| S014 | 2000-06-22 | Normal 180 Day Track |
| S013 | 2000-05-10 | Normal 180 Day Track |
| S012 | 1999-11-12 | Normal 180 Day Track |
| S011 | 1999-09-30 | Normal 180 Day Track |
| S010 | 1999-03-24 | Normal 180 Day Track |
| S009 | 1999-02-04 | Normal 180 Day Track |
| S008 | 1998-10-27 | Normal 180 Day Track |
| S007 | 1998-09-03 | Normal 180 Day Track |
| S006 | 1998-08-24 | Normal 180 Day Track |
| S005 | 1998-06-30 | Real-time Process |
| S004 | 1998-03-30 | Normal 180 Day Track |
| S003 | 1997-12-23 | Normal 180 Day Track |
| S002 | 1997-11-25 | Normal 180 Day Track |
| S001 | 1997-07-10 | Normal 180 Day Track |