HiResolution Bionic Ear System

FDA Premarket Approval P960058 S147

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

A supplier facility move for the manufacturing of implant capacitors

DeviceHiResolution Bionic Ear System
Generic NameImplant, Cochlear
ApplicantADVANCED BIONICS
Date Received2019-12-18
Decision Date2020-01-17
PMAP960058
SupplementS147
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED BIONICS 28515 Westinghouse Place valencia, CA 91355

Supplemental Filings

Supplement NumberDateSupplement Type
P960058Original Filing
S147 2019-12-18 30-day Notice
S146 2019-11-19 30-day Notice
S145
S144
S143 2019-09-25 30-day Notice
S142 2019-08-02 30-day Notice
S141 2019-07-26 30-day Notice
S140 2019-06-03 30-day Notice
S139 2019-05-06 Real-time Process
S138 2019-02-27 30-day Notice
S137 2019-02-04 30-day Notice
S136 2019-01-29 30-day Notice
S135 2018-12-14 30-day Notice
S134 2018-12-13 30-day Notice
S133
S132 2018-09-13 Normal 180 Day Track
S131
S130 2018-07-16 30-day Notice
S129 2018-03-12 Normal 180 Day Track
S128 2018-02-13 30-day Notice
S127
S126 2017-10-26 30-day Notice
S125 2017-09-29 30-day Notice
S124 2017-09-28 30-day Notice
S123 2017-09-05 30-day Notice
S122 2017-06-05 Normal 180 Day Track
S121 2017-05-08 Normal 180 Day Track
S120 2016-11-23 Normal 180 Day Track
S119 2016-07-22 Normal 180 Day Track
S118 2015-08-21 30-day Notice
S117 2015-08-03 Normal 180 Day Track
S116 2015-07-13 Normal 180 Day Track No User Fee
S115 2015-02-18 Normal 180 Day Track
S114 2015-01-02 Normal 180 Day Track
S113 2014-11-13 30-day Notice
S112 2014-11-28 Normal 180 Day Track
S111 2014-09-15 Normal 180 Day Track
S110
S109 2014-04-21 Normal 180 Day Track
S108 2014-02-14 Normal 180 Day Track
S107 2014-01-16 30-day Notice
S106 2013-12-13 Normal 180 Day Track
S105 2013-12-09 30-day Notice
S104 2013-08-19 30-day Notice
S103 2013-07-17 135 Review Track For 30-day Notice
S102 2013-02-04 Normal 180 Day Track
S101 2012-11-19 135 Review Track For 30-day Notice
S100 2012-11-13 Normal 180 Day Track
S099 2012-10-22 Normal 180 Day Track
S098 2012-09-10 Normal 180 Day Track
S097 2012-07-27 30-day Notice
S096 2012-04-11 135 Review Track For 30-day Notice
S095 2011-12-30 Normal 180 Day Track No User Fee
S094 2011-11-02 Normal 180 Day Track
S093 2011-10-21 Normal 180 Day Track
S092 2011-10-03 30-day Notice
S091 2011-09-30 Normal 180 Day Track
S090 2011-06-09 135 Review Track For 30-day Notice
S089 2011-06-01 Normal 180 Day Track
S088
S087 2010-10-22 Real-time Process
S086
S085 2010-05-13 Normal 180 Day Track
S084 2010-04-07 135 Review Track For 30-day Notice
S083
S082 2009-08-28 Normal 180 Day Track
S081 2009-05-13 30-day Notice
S080 2009-03-26 Normal 180 Day Track
S079 2009-02-23 Real-time Process
S078 2009-02-06 30-day Notice
S077
S076 2008-12-01 Normal 180 Day Track
S075 2008-11-18 135 Review Track For 30-day Notice
S074 2008-11-12 135 Review Track For 30-day Notice
S073 2008-11-10 Special (immediate Track)
S072
S071
S070 2008-10-01 30-day Notice
S069
S068
S067
S066 2008-06-02 135 Review Track For 30-day Notice
S065
S064
S063
S062
S061 2008-03-24 Real-time Process
S060
S059
S058 2007-05-07 Normal 180 Day Track
S057 2007-04-18 135 Review Track For 30-day Notice
S056
S055 2006-10-17 135 Review Track For 30-day Notice
S054 2006-07-17 Normal 180 Day Track No User Fee
S053 2006-03-08 Special (immediate Track)
S052
S051
S050 2005-12-23 30-day Notice
S049 2005-12-12 Normal 180 Day Track
S048 2005-11-07 30-day Notice
S047 2005-10-27 Normal 180 Day Track
S046 2005-06-27 Real-time Process
S045 2005-06-27 Normal 180 Day Track
S044
S043 2005-07-05 Normal 180 Day Track
S042 2005-05-03 Normal 180 Day Track No User Fee
S041
S040 2004-12-14 Normal 180 Day Track
S039
S038 2004-07-28 Normal 180 Day Track
S037 2004-05-10 Special (immediate Track)
S036 2004-04-22 Normal 180 Day Track
S035 2004-04-15 30-day Notice
S034 2004-03-03 Normal 180 Day Track
S033 2004-02-09 Real-time Process
S032 2003-12-09 Real-time Process
S031 2003-05-23 Real-time Process
S030 2003-03-18 Normal 180 Day Track
S029 2003-01-13 Normal 180 Day Track
S028 2002-11-01 Normal 180 Day Track
S027 2002-10-25 Real-time Process
S026 2002-10-25 Real-time Process
S025 2002-09-19 Real-time Process
S024 2002-09-16 Real-time Process
S023 2002-07-29 Normal 180 Day Track
S022 2002-05-28 Real-time Process
S021 2002-05-28 Real-time Process
S020 2002-04-12 Real-time Process
S019
S018
S017
S016
S015 2000-11-16 Normal 180 Day Track
S014 2000-06-22 Normal 180 Day Track
S013 2000-05-10 Normal 180 Day Track
S012 1999-11-12 Normal 180 Day Track
S011 1999-09-30 Normal 180 Day Track
S010 1999-03-24 Normal 180 Day Track
S009 1999-02-04 Normal 180 Day Track
S008 1998-10-27 Normal 180 Day Track
S007 1998-09-03 Normal 180 Day Track
S006 1998-08-24 Normal 180 Day Track
S005 1998-06-30 Real-time Process
S004 1998-03-30 Normal 180 Day Track
S003 1997-12-23 Normal 180 Day Track
S002 1997-11-25 Normal 180 Day Track
S001 1997-07-10 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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