PMA P190006S011
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S011
- Product code
- QON
- Decision date
- 2020-07-01
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Approval for the addition of 3T MRI RF Body Coil Conditional to the labeling.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S011
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2020-07-01
- Decision code
- APPR
- Date received
- 2020-04-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of 3T MRI RF Body Coil Conditional to the labeling.