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 |
|---|---|---|---|
| P000025S136 | MED-EL Cochlear Implant System | Med-El Corp. | 2026-10-09 |
| P970051S244 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 2026-09-28 |
| P890027S067 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 2026-09-28 |
| P840024S099 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 2026-09-28 |
| P960058S178 | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | Advanced Bionics | 2026-09-18 |
| P960058S177 | HiResolution Bionic Ear System | Advanced Bionics | 2026-09-04 |
| P960058S167 | HiResolution™ Bionic Ear System | Advanced Bionics | 2026-07-22 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00197420017531 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018132 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018118 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018095 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018071 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018057 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018033 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420018002 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017999 | M Battery | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017654 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017630 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017616 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017593 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017579 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017555 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014578 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017517 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017494 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017470 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420017456 | M Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014776 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014752 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014738 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014714 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014691 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014677 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014653 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014639 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014615 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |
| 00197420014592 | Zn-Air Battery Pak | Advanced Bionics, LLC | 2026-10-23 |