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 dacapo system which is an alternative rechargeable battery pack to power the behind-the-ear speech processor, an external component of the combi 40+ cochlear implant system.
| Device | COMBI 40+ COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | MED-EL CORP. |
| Date Received | 2007-07-18 |
| Decision Date | 2008-03-14 |
| PMA | P000025 |
| Supplement | S026 |
| 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 | 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 |