PMA P190006S101

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S101
Product code: QON
Decision date: 2025-12-19
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: approval for using updated operating parameters on the sterile pouch sealers, as well as qualifying a new duplicate pouch sealer with the updated parameters

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S101
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2025-12-19
Decision code: OK30
Date received: 2025-11-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for using updated operating parameters on the sterile pouch sealers, as well as qualifying a new duplicate pouch sealer with the updated parameters