PMA P190006
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S064
- Product code
- QON
- Decision date
- 2026-07-24
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- minor software update to Axonics External Trial Stimulator (Model ETS-02)
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S110
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-07-24
- Decision code
- APPR
- Date received
- 2026-04-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- minor software update to Axonics External Trial Stimulator (Model ETS-02)