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 incorporation of the size-reduced speech processor to be worn behind the ear, known as the platinum bte(tm) sound processor. The device, as modified, will be marketed under the trade name clarion(r) multi-strategy cochlear implant platinum bte(tm) sound processor. The device is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. Children: 1) two years of age through 17 years, if x-rays demonstrate evidence of ossification, children as yound as 18 months may be implanted. 2) profound, bilateral sensorineural deafness (>=90db) 3) undergone or be willing to undergo a hearing adi trial with appropriately fitted hearing aids 4) lack of benefit from appropriately fitted hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones wuch as a child's inconsistent response to his/her name ion quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set work recognition (phonetically balanced kindergarten test-word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development.
| Device | MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC) |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | ADVANCED BIONICS |
| Date Received | 2000-11-16 |
| Decision Date | 2001-01-12 |
| PMA | P960058 |
| Supplement | S015 |
| Product Code | MCM |
| 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 |