PMA P180046S042
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S042
- Product code
- EZW
- Decision date
- 2021-11-15
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Change in inspection sampling plan of the Axonics IPG case assembly (Model 1101).
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S042
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2021-11-15
- Decision code
- OK30
- Date received
- 2021-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in inspection sampling plan of the Axonics IPG case assembly (Model 1101).