Approval for the addition of a polyterephthalate (pet) mesh disk. The device, as modified, will be marketed under the trade name nucleus 24 auditory brainstem implant with pet mesh disk and is intended to restore useful hearing in individuals with neurofibromatosis type 2 (nf2) who are 12 years of age or older, via electrical stimulation of the cochlear nucleus.
| Device | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 2003-06-24 |
| Decision Date | 2003-08-22 |
| PMA | P000015 |
| Supplement | S005 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| 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