PMA P180046S102
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S102
- Product code
- EZW
- Decision date
- 2026-01-07
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- to perform Bacterial Endotoxin Testing (BET) pre-sterilization
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S102
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-01-07
- Decision code
- OK30
- Date received
- 2025-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to perform Bacterial Endotoxin Testing (BET) pre-sterilization