Identity
- Trade Name
- SetPoint System FDA PMA
- Generic Name
- Vagus nerve stimulator for rheumatoid arthritis FDA PMA
Identifiers
- PMA Number
- P240039 FDA PMA
- FDA Product Code
- SFJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SetPoint System is a Class III vagus nerve stimulator designed for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). It is intended for use in patients who have not responded adequately, lost response, or experienced intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
The device is supplied as a medical implant and has received FDA Premarket Approval (PMA). It is regulated under the PMA process (P240039) and is classified under product code SFJ. The system is intended for clinical use in specialized neurology settings, with no indication of single-use or reusable status, MRI safety classification, or specific storage requirements provided in the regulatory data.
Frequently asked questions
What is the SetPoint System intended to treat, and who is it designed for?
The SetPoint System is a vagus nerve stimulator approved for treating adult patients with moderately to severely active rheumatoid arthritis (RA) who have not responded well, lost effectiveness, or experienced intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). It is not intended for general RA treatment but specifically for patients who meet these criteria.
Is the SetPoint System intended for single-use or reusable applications?
The regulatory data for the SetPoint System does not specify whether it is intended for single-use or reusable applications. Since it is described as a medical implant, it is likely designed for long-term use within the patient, but this should be confirmed with the manufacturer or clinical guidelines.
What type of clinical setting is the SetPoint System intended for?
The SetPoint System is regulated under product code SFJ and is intended for use in specialized neurology settings. This suggests it requires clinical expertise in neurological procedures, likely administered by trained neurologists or specialists in vagus nerve stimulation therapies.
How is the SetPoint System supplied, and are there any special handling requirements mentioned?
The SetPoint System is supplied as a medical implant, but the regulatory data does not provide explicit details on packaging, sterility, or storage requirements. Since it is an implantable device, it would typically require sterile packaging and proper handling per standard medical device protocols. For precise storage instructions, refer to the manufacturer’s instructions for use.
What regulatory pathway was followed for the SetPoint System’s approval, and what does this mean for clinicians?
The SetPoint System received FDA Premarket Approval (PMA) under PMA number P240039, indicating it underwent a rigorous review process to demonstrate safety and effectiveness. Clinicians should confirm compliance with the approved indications and follow the manufacturer’s guidelines for proper use, as this approval is specific to the described patient population and treatment criteria.
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: SetPoint for Windows - Free download and software reviews - CNET Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P240039 | Class III | Active |
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Manufacturer
- Manufacturer
- SetPoint Medical
Sources (1)
- FDA PMA P240039 24 fields · synced Sep 18, 2026