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 a change in clinical guidance for programming nucleus cochlear implant recipients in bipolar mode.
| Device | Nucleus 22 Cochlear Implant System |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 2017-02-09 |
| Decision Date | 2017-12-14 |
| PMA | P890027 |
| Supplement | S058 |
| 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 13059 E Peakview Ave centennial, CO 80111 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890027 | Original Filing | |
| S062 | 2022-04-26 | Normal 180 Day Track |
| S061 | ||
| S060 | 2019-08-15 | Normal 180 Day Track |
| S059 | 2017-05-23 | Normal 180 Day Track |
| S058 | 2017-02-09 | Special (immediate Track) |
| S057 | 2009-10-13 | Special (immediate Track) |
| S056 | 2007-09-14 | Real-time Process |
| S055 | 2002-12-16 | Real-time Process |
| S054 | 2002-12-06 | Normal 180 Day Track |
| S053 | 2002-10-31 | Normal 180 Day Track |
| S052 | 2002-08-28 | Special (immediate Track) |
| S051 | 2001-09-28 | Normal 180 Day Track |
| S050 | 2001-04-19 | Normal 180 Day Track |
| S049 | 2000-11-29 | Normal 180 Day Track |
| S048 | 1999-10-20 | Real-time Process |
| S047 | 1999-04-15 | 30-day Notice |
| S046 | 1998-09-21 | Real-time Process |
| S045 | 1998-08-17 | Normal 180 Day Track |
| S044 | 1998-03-18 | 30-day Notice |
| S043 | 1998-02-09 | Special (immediate Track) |
| S042 | 1997-12-09 | Normal 180 Day Track |
| S041 | 1997-10-02 | Normal 180 Day Track |
| S040 | 1997-09-25 | Normal 180 Day Track |
| S039 | 1997-07-01 | Normal 180 Day Track |
| S038 | 1997-04-24 | Normal 180 Day Track |
| S037 | 1997-02-18 | Normal 180 Day Track |
| S036 | 1996-08-07 | Normal 180 Day Track |
| S035 | 1996-06-20 | Normal 180 Day Track |
| S034 | 1996-06-06 | Normal 180 Day Track |
| S033 | 1996-05-06 | Normal 180 Day Track |
| S032 | 1996-04-25 | Special (immediate Track) |
| S031 | 1996-04-24 | Normal 180 Day Track |
| S030 | 1996-02-23 | Normal 180 Day Track |
| S029 | 1995-11-24 | Normal 180 Day Track |
| S028 | 1995-10-31 | Normal 180 Day Track |
| S027 | 1995-03-03 | Normal 180 Day Track |
| S026 | 1995-02-28 | Normal 180 Day Track |
| S025 | 1994-10-04 | Normal 180 Day Track |
| S024 | ||
| S023 | 1994-05-27 | Normal 180 Day Track |
| S022 | 1994-05-06 | Normal 180 Day Track |
| S021 | 1993-09-30 | Normal 180 Day Track |
| S020 | 1993-09-01 | Normal 180 Day Track |
| S019 | 1993-07-07 | Normal 180 Day Track |
| S018 | 1993-06-03 | Normal 180 Day Track |
| S017 | 1992-09-08 | Normal 180 Day Track |
| S016 | 1992-08-13 | Normal 180 Day Track |
| S015 | 1992-07-23 | Normal 180 Day Track |
| S014 | 1992-04-09 | Normal 180 Day Track |
| S013 | 1992-04-09 | Normal 180 Day Track |
| S012 | 1992-02-06 | Normal 180 Day Track |
| S011 | 1992-02-06 | Normal 180 Day Track |
| S010 | 1992-01-21 | Normal 180 Day Track |
| S009 | 1992-01-13 | Normal 180 Day Track |
| S008 | 1991-12-24 | Normal 180 Day Track |
| S007 | 1991-11-15 | Normal 180 Day Track |
| S006 | 1991-09-20 | Normal 180 Day Track |
| S005 | 1991-08-22 | Normal 180 Day Track |
| S004 | 1991-05-31 | Normal 180 Day Track |
| S003 | 1991-03-27 | Normal 180 Day Track |
| S002 | 1991-02-28 | Normal 180 Day Track |
| S001 | 1991-01-08 | Normal 180 Day Track |