Genesis and Eon Family Spinal Cord Stimulation System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS FDA PMA
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief FDA PMA
Identifiers
- PMA Number
- P010032 FDA PMA
- FDA Product Code
- LGW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Genesis and Eon Family Spinal Cord Stimulation System is a Stimulator, Spinal-Cord, Totally Implanted for Pain Relief, designed to deliver electrical impulses to the spinal cord. It is intended for managing chronic intractable pain in the trunk and/or limbs, including conditions such as failed back surgery syndrome, intractable low back pain, and leg pain.
This system comprises implanted and external components, including the Model 3608 Pulse Generator, Model 3850 Patient Programmer, Model 1232 Programming Wand, and Model 1210 Patient Magnet. Authorized under FDA_PMA (PMA Number: P010032), the device is classified as a Class III medical device and is intended for permanent implantation. It requires surgical placement and is not MRI-safe.
Frequently asked questions
What specific chronic pain conditions is the Genesis and Eon Family Spinal Cord Stimulation System approved to manage?
The Genesis and Eon Family Spinal Cord Stimulation System is FDA-authorized to help manage chronic intractable pain in the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. It is not intended for acute pain or conditions outside these specified indications.
Is the Genesis and Eon Family SCS System designed for temporary or permanent use?
The Genesis and Eon Family Spinal Cord Stimulation System is intended for **permanent implantation** and is not designed for temporary or short-term use. It requires surgical placement and is meant to be left in place long-term for chronic pain management.
Does this system include external components, and if so, what are their primary functions?
Yes, the system includes external components: the **Model 3850 Patient Programmer** (for patient adjustments), the **Model 1232 Programming Wand** (for clinician programming), and the **Model 1210 Patient Magnet** (for activating or deactivating stimulation). These tools allow patients and clinicians to control and modify stimulation parameters as needed.
Can this device be used in an MRI environment, and if not, what safety precautions should be taken?
No, the Genesis and Eon Family Spinal Cord Stimulation System is **not MRI-safe**. Patients with this device implanted should avoid MRI scans, as the electrical components could be damaged by magnetic fields, and the procedure poses risks to both the patient and the imaging equipment.
What is the primary implanted component of this system, and how is it programmed?
The primary implanted component is the **Model 3608 Pulse Generator**, which delivers electrical impulses to the spinal cord. Programming is done using the **Model 1232 Programming Wand** (by clinicians) and the **Model 3850 Patient Programmer** (for patient-controlled adjustments). The **Model 1210 Patient Magnet** can also be used to toggle stimulation on or off.
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. Sources consulted: Genesis - The Official Site
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P010032 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P010032 24 fields · synced Sep 18, 2026