PMA P180046S110
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S110
- Product code
- EZW
- Decision date
- 2026-07-24
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for 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
- P180046
- Supplement
- S110
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for 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)