- Device
- Axonics Sacral Neuromodulation (SNM) System for Urinary Control
- Applicant
- Boston Scientific Corporation
- PMA number
- P190006
- Supplement
- S033
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2021-03-16
- Decision code
- OK30
- Date received
- 2021-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of Heraeus Medical Components as an alternate supplier of the Axonics Leads.