PMA P240031S003
- Device
- Neuspera Sacral Neuromodulation (SNM) System
- Applicant
- Neuspera Medical, Inc.
- PMA number
- P240031
- Supplement
- S003
- Product code
- EZW
- Decision date
- 2026-04-21
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- approval for the addition of the Neuspera Wearable
Current openFDA PMA Record#
- Device
- Neuspera Sacral Neuromodulation (SNM) System
- Applicant
- Neuspera Medical, Inc.
- PMA number
- P240031
- Supplement
- S003
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-04-21
- Decision code
- APPR
- Date received
- 2025-08-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the addition of the Neuspera Wearable