Axonics Sacral Neuromodulation System
FDA premarket approval P190006/S026 · decided 2021-02-03
Approval details
- PMA number
- P190006
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-11-05
- Decision date
- 2021-02-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for an update to the software and associated labeling for the Model 1101 implantable neurostimulator and Model 2501 clinician programmer to support the use of two therapy programs.
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