PMA P180046S062
- Device
- Axonics Sacral Neuromodulation System (Urinary)
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S062
- Product code
- EZW
- Decision date
- 2022-12-19
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Approval for updated labeling information
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System (Urinary)
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S062
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2022-12-19
- Decision code
- APPR
- Date received
- 2022-09-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling information