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 a change to the packaging configuration of your sonatati100 cochlear implant and the implant template, single use, for the sonatati100. This change will enable the sonata single use template to be shipped together with the sonatati100 cochlear implant inside the implant box.
| Device | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | MED-EL CORP. |
| Date Received | 2011-06-20 |
| Decision Date | 2012-04-20 |
| PMA | P000025 |
| Supplement | S054 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MED-EL CORP. furstenweg 77a innsbruck 6020 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000025 | Original Filing | |
| S124 | 2022-02-17 | Real-time Process |
| S123 | 2022-01-26 | Real-time Process |
| S122 | 2021-05-14 | Normal 180 Day Track No User Fee |
| S121 | ||
| S120 | 2020-09-28 | Normal 180 Day Track |
| S119 | 2020-09-21 | 30-day Notice |
| S118 | 2020-08-06 | Normal 180 Day Track No User Fee |
| S117 | ||
| S116 | 2020-05-27 | Real-time Process |
| S115 | ||
| S114 | ||
| S113 | 2019-08-16 | Normal 180 Day Track No User Fee |
| S112 | 2019-05-24 | Real-time Process |
| S111 | ||
| S110 | 2019-03-06 | Real-time Process |
| S109 | 2019-01-31 | Real-time Process |
| S108 | 2019-01-31 | Real-time Process |
| S107 | 2019-01-25 | 30-day Notice |
| S106 | ||
| S105 | 2018-08-20 | 30-day Notice |
| S104 | ||
| S103 | 2018-07-18 | Normal 180 Day Track |
| S102 | 2018-07-12 | 30-day Notice |
| S101 | 2018-06-25 | 30-day Notice |
| S100 | ||
| S099 | 2018-02-14 | Real-time Process |
| S098 | 2018-01-22 | Real-time Process |
| S097 | 2017-12-11 | Normal 180 Day Track |
| S096 | 2017-06-12 | 30-day Notice |
| S095 | 2017-05-05 | 30-day Notice |
| S094 | 2017-03-16 | Normal 180 Day Track |
| S093 | 2017-02-27 | 30-day Notice |
| S092 | 2016-10-13 | Normal 180 Day Track No User Fee |
| S091 | 2016-09-22 | Real-time Process |
| S090 | 2016-08-29 | Real-time Process |
| S089 | 2016-08-22 | Normal 180 Day Track |
| S088 | 2016-06-09 | 30-day Notice |
| S087 | 2016-02-29 | Real-time Process |
| S086 | 2016-02-11 | Real-time Process |
| S085 | 2016-02-01 | Real-time Process |
| S084 | 2015-12-23 | Panel Track |
| S083 | 2015-11-30 | 30-day Notice |
| S082 | 2015-09-04 | Real-time Process |
| S081 | 2014-12-11 | Real-time Process |
| S080 | 2014-08-06 | 30-day Notice |
| S079 | 2014-06-09 | Normal 180 Day Track |
| S078 | 2014-06-09 | Normal 180 Day Track |
| S077 | 2014-04-03 | Real-time Process |
| S076 | 2014-02-20 | 30-day Notice |
| S075 | ||
| S074 | 2013-12-18 | 30-day Notice |
| S073 | 2013-07-19 | 30-day Notice |
| S072 | 2013-07-10 | 135 Review Track For 30-day Notice |
| S071 | 2013-07-10 | 30-day Notice |
| S070 | 2013-06-27 | Real-time Process |
| S069 | 2013-05-06 | 30-day Notice |
| S068 | 2013-03-01 | Real-time Process |
| S067 | 2012-10-26 | Normal 180 Day Track |
| S066 | 2012-11-05 | 30-day Notice |
| S065 | 2012-09-17 | 30-day Notice |
| S064 | 2012-09-04 | Real-time Process |
| S063 | 2012-08-10 | Normal 180 Day Track |
| S062 | 2012-04-05 | Normal 180 Day Track |
| S061 | 2012-02-08 | 30-day Notice |
| S060 | 2011-12-16 | Real-time Process |
| S059 | 2011-10-17 | Real-time Process |
| S058 | 2011-10-17 | Normal 180 Day Track |
| S057 | 2011-10-14 | Normal 180 Day Track |
| S056 | 2011-08-29 | 30-day Notice |
| S055 | 2011-08-04 | 30-day Notice |
| S054 | 2011-06-20 | Real-time Process |
| S053 | 2011-05-31 | 135 Review Track For 30-day Notice |
| S052 | 2011-05-23 | Real-time Process |
| S051 | 2011-04-25 | 135 Review Track For 30-day Notice |
| S050 | 2010-12-27 | Normal 180 Day Track |
| S049 | 2010-07-06 | 30-day Notice |
| S048 | 2010-05-19 | 30-day Notice |
| S047 | 2010-04-28 | 135 Review Track For 30-day Notice |
| S046 | 2010-03-18 | 135 Review Track For 30-day Notice |
| S045 | 2009-12-17 | Normal 180 Day Track |
| S044 | 2009-11-02 | 135 Review Track For 30-day Notice |
| S043 | 2009-07-31 | Real-time Process |
| S042 | 2009-05-04 | Real-time Process |
| S041 | 2009-04-22 | 135 Review Track For 30-day Notice |
| S040 | 2009-02-23 | 30-day Notice |
| S039 | 2009-02-18 | Real-time Process |
| S038 | 2008-09-24 | 30-day Notice |
| S037 | 2008-09-12 | Special (immediate Track) |
| S036 | 2008-06-27 | Normal 180 Day Track No User Fee |
| S035 | 2008-06-25 | Normal 180 Day Track |
| S034 | 2008-05-12 | 30-day Notice |
| S033 | 2008-04-28 | Real-time Process |
| S032 | 2008-03-10 | 30-day Notice |
| S031 | 2008-01-23 | 30-day Notice |
| S030 | ||
| S029 | 2007-10-25 | Normal 180 Day Track |
| S028 | 2007-09-27 | 30-day Notice |
| S027 | 2007-08-27 | Special (immediate Track) |
| S026 | 2007-07-18 | Normal 180 Day Track |
| S025 | 2007-06-29 | 30-day Notice |
| S024 | 2007-06-27 | 30-day Notice |
| S023 | 2007-03-29 | Normal 180 Day Track |
| S022 | ||
| S021 | 2006-12-15 | Normal 180 Day Track |
| S020 | 2006-04-17 | Real-time Process |
| S019 | 2005-07-05 | Real-time Process |
| S018 | 2005-02-04 | 30-day Notice |
| S017 | 2004-12-17 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 2004-03-08 | Normal 180 Day Track |
| S013 | 2004-01-26 | 30-day Notice |
| S012 | 2003-12-16 | Normal 180 Day Track |
| S011 | 2003-06-18 | Normal 180 Day Track No User Fee |
| S010 | 2003-06-16 | Real-time Process |
| S009 | 2003-03-31 | Normal 180 Day Track |
| S008 | 2003-01-21 | Special (immediate Track) |
| S007 | 2002-12-10 | Normal 180 Day Track |
| S006 | 2002-11-01 | Normal 180 Day Track |
| S005 | 2002-10-15 | Real-time Process |
| S004 | 2002-08-20 | Real-time Process |
| S003 | 2002-03-25 | 30-day Notice |
| S002 | 2002-02-21 | Normal 180 Day Track |
| S001 | 2001-12-18 | Normal 180 Day Track |