- Device
- Axonics Sacral Neuromodulation (SNM) System for Urinary Control
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S036
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2021-11-03
- Decision code
- APPR
- Date received
- 2021-04-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate manufacturing site (Grand Rapids, MI) to source sterile pouches.