PMA P190006S017

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S017
Product code: QON
Decision date: 2020-07-10
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Axonics Charging Device uses a printed circuit board assembly (PCBA) that is currently tested manually using test procedure, 120-0113 (VOL# 27, file #009 of original submission). To support an increase in production, Axonics developed a test fixture (# 200-0198-001, built with software 150-0113-001) that automates the tests that are in the original manual test procedure. A complete traceability of test steps in the original manual test procedure to the proposed automated test fixture requirements is provided.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S017
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2020-07-10
Decision code: OK30
Date received: 2020-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Axonics Charging Device uses a printed circuit board assembly (PCBA) that is currently tested manually using test procedure, 120-0113 (VOL# 27, file #009 of original submission). To support an increase in production, Axonics developed a test fixture (# 200-0198-001, built with software 150-0113-001) that automates the tests that are in the original manual test procedure. A complete traceability of test steps in the original manual test procedure to the proposed automated test fixture requirements is provided.