Product code MNQ
- Device name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- AN
- 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 |
|---|---|---|---|
| P250013S001 | aura6000™ system | LivaNova USA, Inc. | 2026-04-30 |
| P130008S138 | Inspire V Printed Circuit Board Assembly (PCBA) Test System SW | Inspire Medical Systems | 2026-04-16 |
| P250013 | aura6000™ system | LivaNova USA, Inc. | 2026-03-18 |
| P130008S137 | Model 3150 Implantable Pulse Generator (IPG) | Inspire Medical Systems | 2026-03-13 |
| P130008S135 | Model 3028 Connector Block Laser Weld Inspection Update | Inspire Medical Systems | 2026-02-23 |
| P130008S124 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2026-02-06 |
| P130008S133 | QMR Battery Separator Supplier | Inspire Medical Systems | 2026-01-30 |
| P130008S132 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2025-12-17 |
| P240024S002 | Genio® System 2.1 | Nyxoah S.A. | 2025-11-06 |
| P130008S130 | Inspire® Upper Airway Stimulation | Inspire Medical Systems | 2025-10-22 |
| P130008S131 | Inspire Upper Airway Stimulation | Inspire Medical Systems | 2025-10-21 |
| P240024S001 | Genio® System 2.1 | Nyxoah S.A. | 2025-10-03 |
| P130008S129 | Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System | Inspire Medical Systems | 2025-09-29 |
| P240024 | Genio® System 2.1 | Nyxoah S.A. | 2025-08-08 |
| P130008S127 | MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG) | Inspire Medical Systems | 2025-07-21 |
| P130008S126 | Inspire® Upper Airway Stimulation (UAS) | Inspire Medical Systems | 2025-06-18 |
| P130008S116 | Inspire Upper Airway Stimulation (UAS) | Inspire Medical Systems | 2025-06-03 |
| P130008S125 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2025-05-30 |
| P130008S122 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2025-05-16 |
| P130008S121 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2025-05-09 |
| P130008S120 | Inspire® Upper Airway Stimulation (UAS) | Inspire Medical Systems | 2025-04-23 |
| P130008S119 | Inspire II Upper Airway Stimulator | Inspire Medical Systems | 2025-03-04 |
| P130008S118 | Inspire Upper Airway Stimulation (UAS) system | Inspire Medical Systems | 2025-02-14 |
| P130008S117 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 2025-01-14 |
| P130008S115 | Inspire® Upper Airway Stimulation (UAS) | Inspire Medical Systems | 2024-12-10 |
| P130008S114 | Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead | Inspire Medical Systems | 2024-11-13 |
| P130008S113 | Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead | Inspire Medical Systems | 2024-08-30 |
| P130008S098 | Inspire Upper Airway Stimulation (UAS) System | Inspire Medical Systems | 2024-08-01 |
| P130008S112 | Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead | Inspire Medical Systems | 2024-06-20 |
| P130008S111 | Inspire Model 3028 Implantable Pulse Generator (IPG) | Inspire Medical Systems | 2024-05-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05404031018723 | Genio System 2.1 | Nyxoah | 2025-08-27 |
| 05404031000001 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031000018 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031000025 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031000049 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031018693 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031024755 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031024786 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031024823 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031024847 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 05404031025301 | Genio System 2.1 | Nyxoah | 2025-08-26 |
| 10855728005793 | Inspire | Inspire Medical Systems, Inc. | 2025-07-29 |
| 10810098650295 | Inspire | Inspire Medical Systems, Inc. | 2025-02-24 |
| 10810098650301 | Inspire | Inspire Medical Systems, Inc. | 2025-02-24 |
| 00810098650311 | Inspire | Inspire Medical Systems, Inc. | 2025-01-21 |
| 10855728005960 | Inspire | Inspire Medical Systems, Inc. | 2024-12-06 |
| 00810098650175 | Inspire | Inspire Medical Systems, Inc. | 2024-10-10 |
| 00810098650199 | Inspire | Inspire Medical Systems, Inc. | 2024-10-10 |
| 00855728005994 | Inspire | Inspire Medical Systems, Inc. | 2024-09-11 |
| 10810098650264 | Inspire | Inspire Medical Systems, Inc. | 2024-07-08 |
| 00810098650038 | Inspire | Inspire Medical Systems, Inc. | 2024-05-15 |
| 00810098650212 | Inspire | Inspire Medical Systems, Inc. | 2024-01-03 |
| 00810098650151 | Inspire | Inspire Medical Systems, Inc. | 2023-04-26 |
| 10810098650141 | Inspire | Inspire Medical Systems, Inc. | 2023-04-06 |
| 00810098650014 | Inspire | Inspire Medical Systems, Inc. | 2023-01-13 |
| 00810098650083 | Inspire | Inspire Medical Systems, Inc. | 2022-09-29 |
| 00855728005796 | Inspire | Inspire Medical Systems, Inc. | 2022-08-16 |
| 00855728005949 | Inspire | Inspire Medical Systems, Inc. | 2022-08-16 |
| 00855728005925 | Inspire | Inspire Medical Systems, Inc. | 2022-05-09 |
| 00810098650007 | Inspire | Inspire Medical Systems, Inc. | 2022-01-26 |