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 to make changes to the mini 22 cochlear implant integrated circuit (ic) test software (k15001) in order to add several test of imporved quality assurance. One modification you have requested is to add a power supply leakage test to aid in ensuring that the bipolar tantalum power supply capacitor is not assembled in the reverse direction. The second modification you have requested is to implement an automatic evaluation of thedata mesured from the integrated circuit prior to its final assembly in order to eliminate operator error
| Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 1995-10-31 |
| Decision Date | 1995-12-11 |
| PMA | P890027 |
| Supplement | S028 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |