PMA P190006S062
- Device
- Axonics Sacral Neuromodulation System (bowel)
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S062
- Product code
- QON
- Decision date
- 2022-12-19
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Approval for updated labeling information.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System (bowel)
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S062
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal 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.