Neuspera Sacral Neuromodulation System
PMA P240031
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240031 | Date17 Jun 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Stimulator, electrical, implantable, for incontinence
- PMA Number
- FDA Product Code
- EZW
- Device Class
- Class III
- Regulation
- 21 CFR Part 876.5270
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Neuspera Sacral Neuromodulation System is an implantable electrical stimulator designed for the treatment of urinary urge incontinence. Classified as a Stimulator, Electrical, Implantable, For Incontinence, it delivers targeted neuromodulation to the sacral nerves to help regulate bladder function in patients who have not responded to conservative therapies or cannot tolerate them.
This system is intended for surgical implantation and is regulated under FDA Premarket Approval (PMA P240031). It is supplied as a sterile, reusable device for use in urology and gastroenterology settings, adhering to regulatory standards outlined in 21 CFR 876.5270. The device is approved for use in patients with refractory urinary urge incontinence and is not intended for single-use applications.
Other devices from Neuspera Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Neuspera Sacral Neuromodulation System intended to treat, and who is it designed for?
The Neuspera Sacral Neuromodulation System is designed to treat **urinary urge incontinence** in patients who have not responded to or cannot tolerate conservative therapies. It delivers targeted electrical stimulation to the sacral nerves to help regulate bladder function, specifically for those with refractory urge incontinence.
Is the Neuspera Sacral Neuromodulation System a single-use or reusable device, and where is it used?
The Neuspera Sacral Neuromodulation System is **not a single-use device**—it is **sterile and reusable** for surgical implantation. It is intended for use in **urology and gastroenterology settings**, where it is implanted to provide long-term neuromodulation therapy.
How is the regulatory approval status of this device determined, and what does that mean for clinicians?
The Neuspera Sacral Neuromodulation System holds **FDA Premarket Approval (PMA P240031)**, meaning it underwent rigorous review by the FDA to demonstrate safety and effectiveness for its intended use. This approval confirms the device meets regulatory standards for treating urinary urge incontinence in eligible patients, as outlined in **21 CFR 876.5270**. Clinicians can rely on this approval when considering it for patients who meet the criteria.
What types of patients is this device approved for, and what are the key clinical considerations?
The device is approved for patients with **refractory urinary urge incontinence** who have failed, could not tolerate, or were not candidates for more conservative treatments. Key considerations include ensuring the patient’s condition aligns with the approved indication and that they are evaluated by a clinician experienced in sacral neuromodulation, as the system requires surgical implantation.