- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S049
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2022-01-25
- Decision code
- OK30
- Date received
- 2022-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Breathoprene material used in the construction of the charging belt due to component obsolescence.