PMA P190006

Device: Axonics SNM System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S064
Product code: QON
Decision date: 2026-06-17
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Adding an additional glovebox laser welding system and weld program to increase production capacity for the manufacturing of IPG 4101.

Current openFDA PMA Record#

Device: Axonics SNM System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S112
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-06-17
Decision code: OK30
Date received: 2026-05-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adding an additional glovebox laser welding system and weld program to increase production capacity for the manufacturing of IPG 4101.