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.
Movement of an existing process step to a later stage of the manufacturing process.
| Device | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | MED-EL CORP. |
| Date Received | 2008-05-12 |
| Decision Date | 2008-06-13 |
| PMA | P000025 |
| Supplement | S034 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |