PMA P180046S104

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S104
Product code: EZW
Decision date: 2026-01-14
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: adding an additional manufacturing process for removal of excess epoxy on the IPG (Model 4101) of the Axonics Sacral Neuromodulation System

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S104
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2026-01-14
Decision code: OK30
Date received: 2025-12-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an additional manufacturing process for removal of excess epoxy on the IPG (Model 4101) of the Axonics Sacral Neuromodulation System