Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Axium Neurostimulator System FDA PMA
- Generic Name
- Dorsal root ganglion stimulator for pain relief FDA PMA
Identifiers
- PMA Number
- P150004 FDA PMA
- FDA Product Code
- PMP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Axium Spinal Modulation Neurostimulator System is a Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) classified as a Class III medical device. It delivers electrical stimulation to the dorsal root ganglion via epidural or intra-spinal leads, targeting chronic intractable pain in the lower limbs associated with Complex Regional Pain Syndrome (CRPS) types I and II in adult patients.
This system is implanted surgically and is intended for long-term use. It is supplied as a sterile, implantable device with associated leads and is regulated under FDA Premarket Approval (PMA P150004). The device operates within MRI-safe parameters as defined by its specifications and requires proper surgical implantation, patient selection, and follow-up as outlined in the approved clinical indications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150004 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P150004 24 fields · synced Sep 18, 2026