PMA P180046S112
- Device
- Axonics SNM System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S112
- Product code
- EZW
- Decision date
- 2026-06-17
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Adding an additional glovebox laser welding system and weld program to increase production capacity for the manufacturing of IPG 4101.
Current openFDA PMA Record#
- Device
- Axonics SNM System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S112
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-06-17
- Decision code
- OK30
- Date received
- 2026-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional glovebox laser welding system and weld program to increase production capacity for the manufacturing of IPG 4101.