HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE

Implant, Cochlear

FDA Premarket Approval P960058 S106

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

Approval for the naida ci aquacase for use with the naida ci q70 sound processor. The naida ci aquacase is an accessory to the hiresolution bionic ear system.

DeviceHIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE
Classification NameImplant, Cochlear
Generic NameImplant, Cochlear
ApplicantADVANCED BIONICS
Date Received2013-12-13
Decision Date2014-09-10
PMAP960058
SupplementS106
Product CodeMCM
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED BIONICS 28515 Westinghouse Place valencia, CA 91355

Supplemental Filings

Supplement NumberDateSupplement Type
P960058Original Filing
S156 2022-08-12 30-day Notice
S155 2022-07-13 30-day Notice
S154 2021-12-17 30-day Notice
S153 2021-03-31 30-day Notice
S152 2021-03-26 30-day Notice
S151 2020-11-27 30-day Notice
S150 2020-06-25 30-day Notice
S149
S148 2020-04-29 30-day Notice
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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