- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S113
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-08-07
- Decision code
- APPR
- Date received
- 2026-06-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for software updates to the Implantable Pulse Generator (IPG) Printed Circuit Board Assembly (PCBA) functional test fixture