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 expansion ofthe indication for use of hte nucleus 22 channel cochlear implant to include children 18 months and older.
| Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 1997-07-01 |
| Decision Date | 1997-12-28 |
| PMA | P890027 |
| Supplement | S039 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day 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 |