Product code PMP
- Device name
- Dorsal Root Ganglion Stimulator For Pain Relief
- 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
- Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150004S094 | Proclaim™ Dorsal Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2026-04-30 |
| P150004S093 | Proclaim™ Doral Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2026-03-13 |
| P150004S085 | Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System | ABBOTT MEDICAL | 2026-01-13 |
| P150004S092 | Proclaim Dorsal Root Ganglion (DRG) System | ABBOTT MEDICAL | 2025-12-23 |
| P150004S090 | Dorsal Root Ganglion (DRG) Neurostimulation System | ABBOTT MEDICAL | 2025-11-07 |
| P150004S088 | Proclaim™ DRG System | ABBOTT MEDICAL | 2025-09-26 |
| P150004S091 | DRG Neurostimulation System | ABBOTT MEDICAL | 2025-09-25 |
| P150004S089 | Proclaim™ Doral Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2025-08-29 |
| P150004S087 | Proclaim DRG IPG | ABBOTT MEDICAL | 2025-07-23 |
| P150004S086 | Proclaim DRG IPG | ABBOTT MEDICAL | 2025-07-02 |
| P150004S082 | Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) | ABBOTT MEDICAL | 2025-03-12 |
| P150004S074 | SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim | ABBOTT MEDICAL | 2025-03-12 |
| P150004S083 | Proclaim™ Dorsal Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2025-02-21 |
| P150004S079 | Proclaim™ Dorsal Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2025-01-13 |
| P150004S080 | NeuroSphere Digital Health Apps | ABBOTT MEDICAL | 2024-12-20 |
| P150004S081 | Axium Neurostimulator System | ABBOTT MEDICAL | 2024-12-13 |
| P150004S077 | Proclaim™ Doral Root Ganglion (DRG) IPG | ABBOTT MEDICAL | 2024-12-03 |
| P150004S078 | Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) | ABBOTT MEDICAL | 2024-10-24 |
| P150004S069 | Axium Neurostimulator System | ABBOTT MEDICAL | 2024-10-08 |
| P150004S076 | Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) | ABBOTT MEDICAL | 2024-08-23 |
| P150004S073 | Axium Neurostimulator System | ABBOTT MEDICAL | 2024-07-24 |
| P150004S075 | DRG Delivery Sheath | ABBOTT MEDICAL | 2024-07-17 |
| P150004S071 | Family of DRG IPGs | ABBOTT MEDICAL | 2024-06-26 |
| P150004S072 | Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base | ABBOTT MEDICAL | 2024-05-16 |
| P150004S070 | Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) | ABBOTT MEDICAL | 2024-04-05 |
| P150004S065 | DRG System - Leads and Extensions | ABBOTT MEDICAL | 2024-01-22 |
| P150004S068 | Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit | ABBOTT MEDICAL | 2024-01-10 |
| P150004S063 | Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor | ABBOTT MEDICAL | 2023-12-19 |
| P150004S052 | Proclaim DRG IPG | ABBOTT MEDICAL | 2023-11-27 |
| P150004S067 | Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories | ABBOTT MEDICAL | 2023-09-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415067054111 | N/A | ADVANCED NEUROMODULATION SYSTEMS, INC. | 2026-03-02 |
| 05415067055880 | Proclaim™ | ADVANCED NEUROMODULATION SYSTEMS, INC. | 2026-02-13 |
| 05415067053060 | NA | ADVANCED NEUROMODULATION SYSTEMS, INC. | 2025-12-07 |
| 05415067050311 | NeuroSphere™ | ADVANCED NEUROMODULATION SYSTEMS, INC. | 2025-01-17 |
| 05415067046956 | NeuroSphere™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067046406 | Proclaim™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067046390 | Proclaim™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067046383 | Proclaim™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067046376 | Proclaim™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067046970 | NeuroSphere™ | ST. JUDE MEDICAL, INC. | 2022-09-01 |
| 05415067020215 | Proclaim™ | ST. JUDE MEDICAL, INC. | 2017-03-23 |
| 05415067026996 | NA | ST. JUDE MEDICAL, INC. | 2017-03-23 |
| 05415067025661 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025654 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025647 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025630 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025623 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025616 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025609 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025593 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025586 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025579 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025562 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025555 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025548 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025531 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025524 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025517 | Axium™ | SPINAL MODULATION, INC. | 2016-03-29 |
| 05415067025500 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |
| 05415067025494 | Axium™ | ST. JUDE MEDICAL, INC. | 2016-03-29 |