Neuspera Sacral Neuromodulation System
FDA premarket approval P240031/S001 · decided 2025-08-15
Approval details
- PMA number
- P240031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Neuspera Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Neuspera Medical, Inc.
- Date received
- 2025-07-18
- Decision date
- 2025-08-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- approval of the protocol for the post-approval study (PAS) of Neuspera Sacral Neuromodulation System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |