PMA P190006S100
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S100
- Product code
- QON
- Decision date
- 2026-03-27
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- changes to the hardware and components of the External Pulse Generator (EPG) trial system
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S100
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-03-27
- Decision code
- APPR
- Date received
- 2025-09-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- changes to the hardware and components of the External Pulse Generator (EPG) trial system