Approval for the use of coupons for residual gas analysis (rga) testing for hermeticity and to remove the requirement of batch release based on rga testing.
| Device | Nucleus Auditory Brainstem Implant System |
| Classification Name | Implant, Auditory Brainstem |
| Generic Name | Implant, Auditory Brainstem |
| Applicant | Cochlear Americas |
| Date Received | 2017-08-25 |
| Decision Date | 2018-02-14 |
| PMA | P000015 |
| Supplement | S026 |
| Product Code | MHE |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 135 Review Track For 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