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 an interim design change for the auria powerpak accessory to the hiresolution bionic ear system. Specifically, you propose the addition of an insulating washer to the auria powerpak assembly while you develop a final design solution for the recently discovered safety issue associated with this device. We note that you agree to design, test, manufacture, and distribute the revised auria powerpak model with the final design solution within six months of the date of this letter. We further note that you agree to submit a supplement to fda for the proposed final design once the design and test activities have been complete and will not distribute the revised auria powerpak without fda approval.
| Device | HIRESOLUTION BIONIC EAR SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | ADVANCED BIONICS |
| Date Received | 2004-07-28 |
| Decision Date | 2004-08-24 |
| PMA | P960058 |
| Supplement | S038 |
| 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 |