PMA P190006S031

Device: Axonics Sacral Neuromodulation (SNM) System for Urinary Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S031
Product code: QON
Decision date: 2021-03-02
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: 1. Changes to manufacturing instructions for a critical device component at a contract manufacturer;2. New inspection procedures for a critical device component; and3. Changes made to the temperature sensor calibration of a critical device component.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation (SNM) System for Urinary Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S031
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-03-02
Decision code: OK30
Date received: 2021-02-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1. Changes to manufacturing instructions for a critical device component at a contract manufacturer;2. New inspection procedures for a critical device component; and3. Changes made to the temperature sensor calibration of a critical device component.