Product code NHL
- Device name
- Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
- 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
- Definition
- Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150031S094 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2026-05-18 |
| P150031S093 | (Vercise Deep Brain Stimulation (DBS) Systems) | Boston Scientific Corp | 2026-05-13 |
| P150031S091 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2026-01-22 |
| P150031S090 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2025-12-17 |
| P150031S089 | Vercise Genus™ Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2025-12-10 |
| P150031S087 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2025-09-19 |
| P150031S086 | VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM | Boston Scientific Corp | 2025-06-25 |
| P150031S085 | VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM | Boston Scientific Corp | 2025-05-29 |
| P150031S083 | Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems | Boston Scientific Corp | 2025-05-20 |
| P150031S082 | Deep Brain Stimulation (DBS) | Boston Scientific Corp | 2025-03-17 |
| P960009S478 | Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System | Medtronic, Inc. | 2025-02-20 |
| P150031S076 | Vercise™ DBS Controller | Boston Scientific Corp | 2025-02-05 |
| P150031S081 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2025-01-08 |
| P150031S080 | Vercise Genus Deep Brain Stimulation System | Boston Scientific Corp | 2024-12-23 |
| P150031S079 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-12-18 |
| P150031S065 | Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System | Boston Scientific Corp | 2024-11-13 |
| P150031S078 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-11-07 |
| P150031S077 | Vercise Genus™ Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-09-04 |
| P150031S073 | Vercise Genus Deep Brain Stimulation (DBS) System | Boston Scientific Corp | 2024-08-06 |
| P150031S075 | Vercise Genus Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-07-26 |
| P150031S074 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-06-21 |
| P150031S068 | Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System | Boston Scientific Corp | 2024-05-14 |
| P150031S071 | Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus™ R32, Vercise Genus™ R16) | Boston Scientific Corp | 2024-03-13 |
| P150031S064 | Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System | Boston Scientific Corp | 2024-02-29 |
| P150031S070 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-02-26 |
| P150031S066 | Vercise Genus Deep Brain Stimulation (DBS) System | Boston Scientific Corp | 2024-01-10 |
| P150031S069 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2024-01-09 |
| P150031S067 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2023-12-29 |
| P150031S062 | Vercise Genus DBS System | Boston Scientific Corp | 2023-11-30 |
| P150031S063 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | 2023-10-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729966333 | Vercise™ Cartesia™ X | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2024-12-15 |
| 08714729966357 | Vercise™ Cartesia™ HX | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2024-12-15 |
| 08714729966364 | Vercise™ Cartesia™ HX | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2024-12-15 |
| 08714729966401 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2024-12-15 |
| 08714729984474 | Vercise™ DBS | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-15 |
| 08714729976691 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2019-01-15 |
| 08714729820802 | SureTek™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820826 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820833 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820857 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820864 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820871 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729820949 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729972518 | Bionic Navigator ™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729905196 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729965817 | Vercise™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-12-15 |
| 08714729821502 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-04-14 |
| 08714729935056 | 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 |
| 08714729821557 | Precision Spectra ™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-11-09 |
| 08714729784456 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-11-09 |
| 08714729767589 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-11-09 |
| 08714729121411 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-11-09 |
| 08714729821533 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-10-10 |
| 08714729792833 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2015-08-20 |
| 10673978868827 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 10681490077139 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 10681490077184 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 10681490077887 | NA | MEDTRONIC, INC. | 2014-09-23 |