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 following changes to the medical procedures manual (mpm) aw33290 en us of the labeling: 1) change to allow diagnostic ultrasound exposure for med-el cochlear implants;2) changes related to mri (mpm section "magnetic resonance imaging (mri) safety information");3) addition of some introductory text;4) correction of mri condition for sonata and mi1000 concert (pin); and5) editorial changes.
| Device | MED-EL Cochlear Implants |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | MED-EL CORP. |
| Date Received | 2018-01-22 |
| Decision Date | 2018-04-20 |
| PMA | P000025 |
| Supplement | S098 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |