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 in the labeling: 1) informational statements regarding meningitis, the use of prophylactic antibiotics, and vaccinations 2) informational statements regarding electrostatic discharge (esd) preventions.
Device | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS |
Classification Name | Implant, Cochlear |
Generic Name | Implant, Cochlear |
Applicant | MED-EL CORP. |
Date Received | 2003-01-21 |
Decision Date | 2003-03-25 |
PMA | P000025 |
Supplement | S008 |
Product Code | MCM |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | Ear Nose & Throat |
Supplement Type | Special (immediate Track) |
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 |