Addition of an alternate printed circuit board (pcb) supplier for the cp800 and cp900 sound processor coils for the nucleus 24 cochlear implant system, the nucleus hybrid l24 implant system and the nucleus abi541 auditory brainstem implant system.
| Device | Nucleus ABI541 Auditory Brainstem Implant |
| Classification Name | Implant, Auditory Brainstem |
| Generic Name | Implant, Auditory Brainstem |
| Applicant | Cochlear Americas |
| Date Received | 2017-03-23 |
| Decision Date | 2017-04-21 |
| PMA | P000015 |
| Supplement | S019 |
| Product Code | MHE |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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