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 the modifications to the device fitting software for adults and pediatrics. The device, as modified, will be marketed under the trade name clarion multi-strategy cochlear implant (adult) and (pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.
| Device | CLARION DEVICE FITTING SOFTWARE (SCLIN) |
| Applicant | ADVANCED BIONICS |
| Date Received | 1999-03-24 |
| Decision Date | 1999-07-16 |
| PMA | P960058 |
| Supplement | S010 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |