Axonics Sacral Neuromodulation System
FDA premarket approval P190006 · Implanted electrical device intended for treatment of fecal incontinence
PMA numberP190006
Approval
- Applicant
- Boston Scientific Corporation
- Received
- March 4, 2019
- Decision date
- September 6, 2019 (APPR)
- Supplements
- 103, latest August 7, 2026
- Product code
- QON – Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Approval order statement
Approval for the Axonics Sacral Neuromodulation System. This device is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.