- Device
- Axonics Sacral Neuromodulation System (Bowel)
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S061
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2022-11-01
- Decision code
- APPR
- Date received
- 2022-09-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Cirtec Medical Corporation, 99 Print Shop Road Enfield, CT 06082 as an alternate contract ethylene oxide sterilization facility for the Axonics Neurostimulator, Model 4101.