Product code MHY
- Device name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- NE
- 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 |
|---|---|---|---|
| P960009S535 | Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (3387S, 3389S, 3550-05, B31010) | Medtronic, Inc. | 2026-05-22 |
| P960009S531 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-05-20 |
| P960009S534 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-05-13 |
| P960009S533 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-05-07 |
| P140009S131 | Infinity™ Deep Brain Stimulation (DBS) IPG; Liberta RC™ DBS IPG | ABBOTT MEDICAL | 2026-04-30 |
| P140009S130 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | ABBOTT MEDICAL | 2026-04-25 |
| P960009S532 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-04-03 |
| P140009S129 | Infinity™ Deep Brain Stimulation (DBS) IPG | ABBOTT MEDICAL | 2026-03-13 |
| P960009S530 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-02-27 |
| P960009S528 | DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 | Medtronic, Inc. | 2026-02-12 |
| P960009S520 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2026-02-11 |
| P140009S126 | 8CH Infinity™ DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity™ DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity™ DBS Lead Kit, 40cm, 0 | ABBOTT MEDICAL | 2026-02-11 |
| P140009S128 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | ABBOTT MEDICAL | 2026-02-10 |
| P960009S529 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros | Medtronic, Inc. | 2026-02-06 |
| P140009S127 | Infinity™ Deep Brain Stimulation (DBS) System | ABBOTT MEDICAL | 2025-12-23 |
| P960009S527 | Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense | Medtronic, Inc. | 2025-12-22 |
| P960009S526 | Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense | Medtronic, Inc. | 2025-12-18 |
| P960009S514 | Activa™ Deep Brain Stimulation Therapy System | Medtronic, Inc. | 2025-12-17 |
| P960009S524 | Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ | Medtronic, Inc. | 2025-12-08 |
| P960009S525 | Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ | Medtronic, Inc. | 2025-11-26 |
| P960009S521 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2025-11-13 |
| P140009S124 | Deep Brain Stimulation (DBS) Neurostimulation System | ABBOTT MEDICAL | 2025-11-07 |
| P960009S523 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2025-10-23 |
| P960009S522 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2025-10-16 |
| P140009S122 | Infinity™ DBS System | ABBOTT MEDICAL | 2025-09-26 |
| P140009S125 | DBS Neurostimulation System | ABBOTT MEDICAL | 2025-09-25 |
| P960009S518 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable B35200); (DBS Ne | Medtronic, Inc. | 2025-09-18 |
| P960009S519 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2025-09-15 |
| P140009S121 | Liberta RC™ DBS IPG | ABBOTT MEDICAL | 2025-09-07 |
| P960009S517 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | 2025-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199309002416 | N/A | MEDTRONIC, INC. | 2026-05-29 |
| 08714729966333 | Vercise™ Cartesia™ X | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2024-12-15 |
| 08714729905288 | Vercise™ Cartesia™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-20 |
| 08714729905271 | Vercise™ Cartesia™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-20 |
| 08714729965831 | Vercise™ DBS | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-15 |
| 08714729952145 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-15 |
| 08714729940876 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-15 |
| 08714729896104 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729905295 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729905196 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729896111 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729896098 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729836544 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729836490 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820987 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820956 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820819 | SureTek™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820802 | SureTek™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820796 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820789 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820772 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820765 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729931751 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-12 |
| 08714729965848 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-12 |
| 08714729935131 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-12 |
| 08714729935148 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-12 |
| 08714729821502 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-04-14 |
| 08714729935063 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-04-14 |
| 08714729762751 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-11-09 |
| 08714729792833 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-08-20 |