- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S017
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for 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