Axonics Sacral Neuromodulation System
FDA premarket approval P190006/S038 · decided 2022-03-07
Approval details
- PMA number
- P190006
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- 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
- 2021-06-25
- Decision date
- 2022-03-07
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for a non-rechargeable Axonics Implantable Pulse Generator (IPG).
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