Product code MHE
- Device name
- Implant, Auditory Brainstem
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000015S056 | Cochlear Auditory Brainstem Implant System | Cochlear Americas | 2026-04-30 |
| P000015S053 | Nucleus® 24 Auditory Brainstem Implant System | Cochlear Americas | 2025-07-03 |
| P000015S054 | Nucleus® 24 Auditory Brainstem Implant System | Cochlear Americas | 2024-05-31 |
| P000015S052 | Nucleus® Auditory Brainstem Implant | Cochlear Americas | 2023-12-13 |
| P000015S051 | Nucleus® 24 Auditory Brainstem Implant System | Cochlear Americas | 2023-10-25 |
| P000015S050 | Nucleus® 24 Auditory Brainstem Implant System | Cochlear Americas | 2023-10-13 |
| P000015S049 | Nucleus 24 Auditory Brainstem Implant System | Cochlear Americas | 2023-04-24 |
| P000015S048 | Nucleus 24 Auditory Brainstem Implant System | Cochlear Americas | 2022-12-06 |
| P000015S047 | Nucleus Auditory Brainstem Implant | Cochlear Americas | 2022-10-31 |
| P000015S046 | Nucleus® Auditory Brainstem Implant System | Cochlear Americas | 2021-12-07 |
| P000015S040 | Nucleus ABI541 Auditory Brainstem Implant System | Cochlear Americas | 2021-06-09 |
| P000015S044 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2020-12-30 |
| P000015S045 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2020-12-08 |
| P000015S043 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2020-08-13 |
| P000015S041 | Nucleus Auditory Brainstem Implant | Cochlear Americas | 2020-07-02 |
| P000015S042 | Nucleus ABI541 Auditory Brainstem Implant | Cochlear Americas | 2019-12-13 |
| P000015S038 | Nucleus ABI541 Auditory Brainstem Implant | Cochlear Americas | 2019-12-04 |
| P000015S036 | Nucleus Auditory Brainstem Implant | Cochlear Americas | 2019-11-08 |
| P000015S039 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2019-08-27 |
| P000015S037 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2019-07-02 |
| P000015S034 | Nucleus ABI541 Auditory Brainstem Implant | Cochlear Americas | 2019-06-05 |
| P000015S035 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2019-03-08 |
| P000015S033 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2018-09-10 |
| P000015S027 | Nucleus Auditory Brainstem Implant | Cochlear Americas | 2018-06-13 |
| P000015S032 | Nucleus 24 Auditory Brainstem Implant | Cochlear Americas | 2018-05-11 |
| P000015S031 | Nucleus AB1541 Auditory Brainstem Implant | Cochlear Americas | 2018-03-16 |
| P000015S030 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2018-03-02 |
| P000015S026 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2018-02-14 |
| P000015S029 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2018-02-01 |
| P000015S028 | Nucleus Auditory Brainstem Implant System | Cochlear Americas | 2018-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09321502020404 | Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant | COCHLEAR LIMITED | 2016-09-20 |