MED-EL Cochlear Implant System

FDA Premarket Approval P000025 S119

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.

Pre-market Approval Supplement Details

Introduction of two additional new sterilization chambers at the contract sterilizer

DeviceMED-EL Cochlear Implant System
Generic NameImplant, Cochlear
ApplicantMED-EL CORP.
Date Received2020-09-21
Decision Date2020-10-21
PMAP000025
SupplementS119
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MED-EL CORP. furstenweg 77a innsbruck 6020

Supplemental Filings

Supplement NumberDateSupplement Type
P000025Original Filing
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

NIH GUDID Devices

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