- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S052
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2022-04-20
- Decision code
- OK30
- Date received
- 2022-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove high potential testing (hipot) from receiving inspection for the tined lead when redundant with hipot testing done by the tined lead contract manufacturer.