PMA P190006S027
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- Product code
- QON
- Decision date
- 2021-09-16
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Approval to increase the maximum sterilization load.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S027
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-09-16
- Decision code
- APPR
- Date received
- 2020-11-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to increase the maximum sterilization load.