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.
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
| Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 1996-04-25 |
| Decision Date | 1996-06-20 |
| PMA | P840024 |
| Supplement | S063 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 400 Inverness Parkway, suite 400 englewood, CO 80112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840024 | Original 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 |