PMA P180046S006
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- Product code
- EZW
- Decision date
- 2020-06-02
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Approval for an update to the Patient Remote software.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S006
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2020-06-02
- Decision code
- APPR
- Date received
- 2020-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the Patient Remote software.