PMA P180046S108

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S108
Product code: EZW
Decision date: 2026-02-25
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: approval of an alternate capacitor component used in the production of Printed Circuit Board Assemblies (PCBAs) for the External Pulse Generator (EPG) in the Axonics Sacral Neuromodulation System

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S108
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2026-02-25
Decision code: OK30
Date received: 2026-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of an alternate capacitor component used in the production of Printed Circuit Board Assemblies (PCBAs) for the External Pulse Generator (EPG) in the Axonics Sacral Neuromodulation System