- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S026
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-02-03
- Decision code
- APPR
- Date received
- 2020-11-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the software and associated labeling for the Model 1101 implantable neurostimulator and Model 2501 clinician programmer to support the use of two therapy programs.