Brio Neurostimulation System Leads, Adaptors, and Extensions
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- BRIO NEUROSTIMULATION SYSTEM FDA PMA
- Generic Name
- Stimulator, electrical, implanted, for parkinsonian tremor FDA PMA
Identifiers
- PMA Number
- P140009 FDA PMA
- FDA Product Code
- MHY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Brio Neurostimulation System Leads, Adaptors, and Extensions are electrical, implanted stimulators designed for deep brain and spinal cord stimulation. These devices are classified as Class III medical devices and include leads for bilateral stimulation of the subthalamic nucleus (STN) and ventral intermediate nucleus (VIM) of the thalamus, intended to manage advanced Parkinson’s disease symptoms and essential tremor unresponsive to medication.
These components are supplied sterile and intended for single-use implantation. They are regulated under FDA PMA approval (P140009) and are used in neurosurgical settings for adjunctive therapy in advanced neurological conditions. The system adheres to strict MRI safety guidelines and is distributed with detailed surgical instructions for proper placement and connection. Authorisations include FDA_PMA, with specific product codes (MHY) and registration numbers listed in the OpenFDA database.
Frequently asked questions
What conditions are these leads designed to treat?
The Brio Neurostimulation System Leads are designed for bilateral stimulation of the subthalamic nucleus (STN) to manage advanced Parkinson's disease symptoms unresponsive to medication, and for unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus to suppress disabling upper extremity tremor in essential tremor patients not adequately controlled by medications.
Are these devices reusable or single-use?
The Brio Neurostimulation System Leads, Adaptors, and Extensions are supplied sterile and intended for single-use implantation only. They should not be reused or resterilized for patient safety and regulatory compliance.
What regulatory approvals do these devices have?
The Brio Neurostimulation System Leads are classified as Class III medical devices and have received FDA PMA approval (P140009). They are regulated under this approval pathway for use in neurosurgical settings as adjunctive therapy for specified neurological conditions.
Are there specific size or model options available?
The device data does not specify different sizes or models of the leads. The Brio Neurostimulation System Leads are designed for bilateral stimulation of specific brain regions (STN and VIM) and are supplied as single-use components for implantation procedures.
What safety guidelines should be followed with these devices?
The Brio Neurostimulation System adheres to strict MRI safety guidelines. Surgical instructions are provided with the device for proper placement and connection. The system should be used according to these guidelines to ensure patient safety and proper functioning of the neurostimulation therapy.
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: Spinal cord - Wikipedia, Spinal Cord: Anatomy, Function & Structure - Cleveland Clinic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140009 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P140009 24 fields · synced Sep 18, 2026