Approval for a new cochleartm cp1000 nucleus n7 sound processor, which is an external component of the nucleus 24 cochlear implant system, the nucleus hybrid l24 implant system, and the nucleus auditory brainstem implant system.
| Device | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Classification Name | Implant, Auditory Brainstem |
| Generic Name | Implant, Auditory Brainstem |
| Applicant | Cochlear Americas |
| Date Received | 2016-10-12 |
| Decision Date | 2017-06-13 |
| PMA | P000015 |
| Supplement | S016 |
| Product Code | MHE |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000015 | | Original Filing |
| S048 |
2022-09-07 |
Real-time Process |
| S047 |
2022-04-26 |
Normal 180 Day Track |
| S046 |
2021-06-21 |
135 Review Track For 30-day Notice |
| S045 |
2020-11-12 |
30-day Notice |
| S044 | | |
| S043 |
2020-07-15 |
30-day Notice |
| S042 |
2019-11-13 |
30-day Notice |
| S041 | | |
| S040 | | |
| S039 |
2019-07-31 |
30-day Notice |
| S038 | | |
| S037 |
2019-06-06 |
30-day Notice |
| S036 | | |
| S035 |
2019-01-30 |
30-day Notice |
| S034 |
2018-11-01 |
Normal 180 Day Track |
| S033 |
2018-08-13 |
30-day Notice |
| S032 |
2018-04-13 |
30-day Notice |
| S031 |
2018-02-15 |
30-day Notice |
| S030 |
2018-02-02 |
30-day Notice |
| S029 |
2018-01-02 |
30-day Notice |
| S028 |
2018-01-02 |
30-day Notice |
| S027 |
2017-11-13 |
Normal 180 Day Track |
| S026 |
2017-08-25 |
135 Review Track For 30-day Notice |
| S025 |
2017-08-07 |
30-day Notice |
| S024 |
2017-07-26 |
30-day Notice |
| S023 |
2017-06-21 |
Real-time Process |
| S022 |
2017-06-07 |
30-day Notice |
| S021 |
2017-05-16 |
30-day Notice |
| S020 |
2017-04-10 |
30-day Notice |
| S019 |
2017-03-23 |
30-day Notice |
| S018 |
2016-11-23 |
30-day Notice |
| S017 |
2016-11-23 |
30-day Notice |
| S016 |
2016-10-12 |
Normal 180 Day Track |
| S015 |
2016-09-22 |
30-day Notice |
| S014 |
2016-06-23 |
30-day Notice |
| S013 | | |
| S012 |
2015-12-18 |
Normal 180 Day Track |
| S011 |
2009-10-13 |
Special (immediate Track) |
| S010 |
2007-12-03 |
Real-time Process |
| S009 | | |
| S008 |
2006-09-05 |
30-day Notice |
| S007 | | |
| S006 |
2005-03-09 |
30-day Notice |
| S005 |
2003-06-24 |
Real-time Process |
| S004 |
2002-12-06 |
Normal 180 Day Track |
| S003 |
2002-10-31 |
Normal 180 Day Track |
| S002 |
2001-07-23 |
Normal 180 Day Track |
| S001 |
2001-06-22 |
Normal 180 Day Track |
NIH GUDID Devices