Axonics Sacral Neuromodulation System
FDA premarket approval P180046/S079 · decided 2025-01-27
Approval details
- PMA number
- P180046
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-01-26
- Decision date
- 2025-01-27
- Days to decision
- 367 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- the accessory called the Axonics Foramen Finder, which consists of the Foramen Finder Guide and the associated Foramen Finder Software
Class III intelligence, same tools
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510(k) clearances by this applicant
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|---|---|---|
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| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |