Neuspera Sacral Neuromodulation System
FDA premarket approval P240031 · decided 2025-06-17
Approval details
- PMA number
- P240031
- Trade name
- Neuspera Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Neuspera Medical, Inc.
- Date received
- 2024-09-23
- Decision date
- 2025-06-17
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval of the Neuspera Sacral Neuromodulation System. The device is indicated for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Neuspera Nuity System (K221303) | Neuspera Medical, Inc. | 2023-04-11 |
| Neuspera Neurostimulation System (NNS) (K202781) | Neuspera Medical, Inc. | 2021-08-27 |