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.
Improvement to the hiresolution bionic ear system¿s hybrid inspection process.
| Device | HIRESOLUTION BIONIC EAR SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | ADVANCED BIONICS |
| Date Received | 2012-11-19 |
| Decision Date | 2013-09-17 |
| PMA | P960058 |
| Supplement | S101 |
| 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 | 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 |