Product code MCM
- Device name
- Implant, Cochlear
- 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
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P970051S242 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2026-04-30 |
| P960058S175 | HiResolution™ Bionic Ear System | Advanced Bionics | 2026-04-16 |
| P960058S173 | HiResolution Bionic Ear System | Advanced Bionics | 2026-04-16 |
| P960058S174 | HiResolution™ Bionic Ear System Ultra and Ultra 3D Thin PCB | Advanced Bionics | 2026-04-09 |
| P960058S170 | HiResolution Bionic Ear System | Advanced Bionics | 2026-01-23 |
| P000025S137 | MED-EL Cochlear Implant | Med-El Corp. | 2026-01-23 |
| P970051S240 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | 2025-12-19 |
| P000025S134 | MED-EL CI System | Med-El Corp. | 2025-11-26 |
| P970051S236 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2025-10-16 |
| P960058S172 | HiResolution™ Bionic Ear System | Advanced Bionics | 2025-10-14 |
| P970051S238 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2025-09-26 |
| P970051S237 | Cochlear™ Nucleus® System | Cochlear Americas | 2025-09-02 |
| P960058S171 | HiResolution™ Bionic Ear System | Advanced Bionics | 2025-08-20 |
| P970051S235 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2025-08-06 |
| P970051S234 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2025-07-24 |
| P970051S225 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2025-07-03 |
| P890027S064 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 2025-07-03 |
| P840024S096 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 2025-07-03 |
| P000025S135 | COMBI 40+ COCHLEAR IMPLANT SYSTEM | Med-El Corp. | 2025-04-24 |
| P960058S168 | HiResolution Bionic Ear System | Advanced Bionics | 2025-04-09 |
| P970051S233 | Nucleus 24 Cochlear Implant System | Cochlear Americas | 2025-02-28 |
| P000025S131 | SONNET 3 (EAS) Audio Processor, MAESTRO 11 | Med-El Corp. | 2025-02-13 |
| P960058S165 | HiResolution Bionic Ear System | Advanced Bionics | 2025-01-29 |
| P960058S166 | HiResolution Bionic Ear System | Advanced Bionics | 2024-12-18 |
| P970051S231 | Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant | Cochlear Americas | 2024-11-15 |
| P970051S232 | Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant | Cochlear Americas | 2024-11-13 |
| P970051S230 | Cochlear™ Slimline™ Coil, Cochlear™ Slimline™ Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil | Cochlear Americas | 2024-10-25 |
| P970051S229 | Nucleus 24 Cochlear Implant System | Cochlear Americas | 2024-10-25 |
| P000025S129 | MED-EL CI System | Med-El Corp. | 2024-10-03 |
| P000025S133 | MED-EL Cochlear Implant System | Med-El Corp. | 2024-09-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630016880704 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-12 |
| 07630016880698 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-12 |
| 07630016880681 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-12 |
| 07630016880674 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880667 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880650 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880636 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880629 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880612 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880605 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880599 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-11 |
| 07630016880582 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-08 |
| 07630016880575 | Slim HP Color Cap | Advanced Bionics AG | 2021-02-08 |
| 07630016852886 | HiFocus™ Electrode Forceps Kit | Advanced Bionics AG | 2017-11-15 |
| 07630016854262 | SoundWave™ Professional Suite Software | Advanced Bionics AG | 2017-07-21 |
| 07630016850578 | SoundWave™ Professional Suite Software | Advanced Bionics AG | 2017-05-24 |
| 07630016840906 | HiRes™ Ultra Magnet Pusher Tool | Advanced Bionics AG | 2017-01-20 |
| 07630016840890 | HiRes™ Ultra Magnet Insertion Tool | Advanced Bionics AG | 2017-01-20 |
| 07630016840883 | HiRes™ Ultra Coil Gauge | Advanced Bionics AG | 2017-01-20 |
| 07630016840876 | HiRes™ Ultra Recess Gauge | Advanced Bionics AG | 2017-01-20 |
| 07630016827730 | HiRes™ Ultra BTE Template | Advanced Bionics AG | 2017-01-20 |
| 07630016826382 | SoundWave™ Professional Suite Software 3.0 | Advanced Bionics AG | 2016-09-23 |
| 07630016842177 | SoundWave™ Professional Suite Software | Advanced Bionics AG | 2015-10-30 |
| 07630016809958 | Helix Cochleostomy Sizing Gauge | Advanced Bionics, LLC | 2015-10-14 |
| 07630016809927 | Electrode Claw Tool | Advanced Bionics, LLC | 2015-10-14 |
| 07630016809606 | Electrode Insertion Tool | Advanced Bionics, LLC | 2015-10-08 |
| 07630016809989 | Recess Marking Template for HiRes 90K™ | Advanced Bionics, LLC | 2015-10-08 |
| 07630016809965 | BTE-ICS Template for HiRes 90K | Advanced Bionics, LLC | 2015-10-08 |
| 07630016809941 | Coil Gauge for HiRes 90K™ | Advanced Bionics, LLC | 2015-10-08 |
| 07630016809934 | Recess Gauge for HiRes 90K™ | Advanced Bionics, LLC | 2015-10-08 |