PMA P180046S101

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S101
Product code: EZW
Decision date: 2025-12-19
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for 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: P180046
Supplement: S101
Product code: EZW
Generic name: Stimulator, electrical, implantable, for 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