NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Premarket Approval P840024 S063

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 revisions to the warnings section in the pacakge insert and patient identification card for the nucleus 22 cochlear implant system. The revisions clarify the warning on the use of monopolar electrosurgical instruments on implant patients and provides use of monopolar electrosurgical instruments on implant patients and provides addtionial instructions for the safe use of bipolar instruments

DeviceNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification NameImplant, Cochlear
Generic NameImplant, Cochlear
ApplicantCochlear Americas
Date Received1996-04-25
Decision Date1996-06-20
PMAP840024
SupplementS063
Product CodeMCM
Advisory CommitteeEar Nose & Throat
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Cochlear Americas 400 Inverness Parkway, suite 400 englewood, CO 80112

Supplemental Filings

Supplement NumberDateSupplement Type
P840024Original Filing
S094 2022-04-26 Normal 180 Day Track
S093
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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