PMA P190006S034

Device: Axonics Sacral Neuromodulation (SNM) System Bowel Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S034
Product code: QON
Decision date: 2021-03-25
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Updates related to the pre-cutting of the polyurethane extrusion and a change in the color of the ETFE insulation for the Percutaneous Extension component.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation (SNM) System Bowel Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S034
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-03-25
Decision code: OK30
Date received: 2021-02-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates related to the pre-cutting of the polyurethane extrusion and a change in the color of the ETFE insulation for the Percutaneous Extension component.