Nucleus 22 Cochlear Implant Systems

FDA Premarket Approval P840024 S092

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

An approval order should be issued for kanso 2 sound processor and associated accessories, nucleus 7 for nucleus 22, smartnav system including smartnav app and cp1150s surgical processor, and custom sound pro.

DeviceNucleus 22 Cochlear Implant Systems
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received2019-11-13
Decision Date2020-07-02
PMAP840024
SupplementS092
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 400 Inverness Parkway, suite 400 englewood, CO 80112

Supplemental Filings

Supplement NumberDateSupplement Type
P840024Original Filing
S092 2019-11-13 Normal 180 Day Track
S091
S090 2017-05-23 Normal 180 Day Track
S089 2017-02-09 Special (immediate Track)
S088 2009-10-13 Special (immediate Track)
S087 2007-09-14 Real-time Process
S086 2002-12-16 Real-time Process
S085 2002-12-06 Normal 180 Day Track
S084 2002-10-31 Normal 180 Day Track
S083 2002-08-28 Special (immediate Track)
S082 2001-09-28 Normal 180 Day Track
S081 2001-04-19 Normal 180 Day Track
S080 2000-11-29 Normal 180 Day Track
S079 1999-10-20 Real-time Process
S078 1999-04-15 30-day Notice
S077 1998-09-21 Real-time Process
S076 1998-08-17 Normal 180 Day Track
S075 1998-03-18 30-day Notice
S074 1998-02-09 Special (immediate Track)
S073 1997-12-09 Normal 180 Day Track
S072 1997-10-02 Normal 180 Day Track
S071 1997-09-25 Normal 180 Day Track
S070 1997-04-24 Normal 180 Day Track
S069 1997-02-18 Normal 180 Day Track
S068 1996-12-09 Normal 180 Day Track
S067 1996-08-07 Normal 180 Day Track
S066 1996-06-20 Normal 180 Day Track
S065 1996-06-06 Normal 180 Day Track
S064 1996-05-06 Normal 180 Day Track
S063 1996-04-25 Special (immediate Track)
S062 1996-04-24 Normal 180 Day Track
S061 1996-02-23 Normal 180 Day Track
S060 1995-11-24 Normal 180 Day Track
S059 1995-10-31 Normal 180 Day Track
S058 1995-07-06 Normal 180 Day Track
S057 1995-03-03 Normal 180 Day Track
S056 1995-02-28 Normal 180 Day Track
S055 1994-10-04 Normal 180 Day Track
S054
S053 1994-05-27 Normal 180 Day Track
S052 1994-05-06 Normal 180 Day Track
S051 1993-09-30 Normal 180 Day Track
S050 1993-09-01 Normal 180 Day Track
S049 1993-07-07 Normal 180 Day Track
S048 1993-06-03 Normal 180 Day Track
S047 1992-09-08 Normal 180 Day Track
S046 1992-08-28 Panel Track
S045 1992-08-13 Normal 180 Day Track
S044 1992-07-23 Normal 180 Day Track
S043 1992-04-09 Normal 180 Day Track
S042 1992-04-09 Normal 180 Day Track
S041 1992-02-06 Normal 180 Day Track
S040 1992-02-06 Normal 180 Day Track
S039 1992-01-21 Normal 180 Day Track
S038 1992-01-13 Normal 180 Day Track
S037 1991-12-24 Normal 180 Day Track
S036 1991-11-15 Normal 180 Day Track
S035 1991-09-20 Normal 180 Day Track
S034 1991-08-22 Normal 180 Day Track
S033 1991-05-31 Normal 180 Day Track
S032 1991-03-27 Normal 180 Day Track
S031 1991-02-28 Normal 180 Day Track
S030 1990-12-12 Normal 180 Day Track
S029 1990-09-12 Normal 180 Day Track
S028 1990-08-24 Normal 180 Day Track
S027 1990-08-16 Normal 180 Day Track
S026 1990-06-04 Normal 180 Day Track
S025 1990-03-28 Normal 180 Day Track
S024 1990-03-06 Normal 180 Day Track
S023 1989-11-24 Normal 180 Day Track
S022 1989-07-19 Normal 180 Day Track
S021 1989-05-31 Normal 180 Day Track
S020 1989-01-13 Normal 180 Day Track
S019 1988-10-13 Normal 180 Day Track
S018 1988-03-21 Normal 180 Day Track
S017 1988-02-22 Normal 180 Day Track
S016
S015 1987-12-31 Normal 180 Day Track
S014 1987-12-07 Normal 180 Day Track
S013 1987-08-24 Normal 180 Day Track
S012 1987-08-24 Normal 180 Day Track
S011 1987-08-10 Normal 180 Day Track
S010 1987-07-08 Normal 180 Day Track
S009 1987-06-29 Normal 180 Day Track
S008 1987-05-11 Normal 180 Day Track
S007 1987-05-08 Normal 180 Day Track
S006 1987-03-25 Normal 180 Day Track
S005 1986-12-04 Normal 180 Day Track
S004
S003 1986-06-26 Normal 180 Day Track
S002 1986-05-15
S001 1985-11-19

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