- Device
- Axonics Sacral Neuromodulation (SNM) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S001
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2020-01-14
- Decision code
- APPR
- Date received
- 2019-10-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an updated software for the Axonics Clinician Programmer (CP), model 2501 (Software Version 416).