Axonics Sacral Neuromodulation System
FDA premarket approval P180046/S092 · decided 2024-11-25
Approval details
- PMA number
- P180046
- Supplement
- S092
- 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
- 2024-10-21
- Decision date
- 2024-11-25
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval of the addition of an alternate supplier of the titanium housing used in implantable pulse generator (IPG) model 4101 of the Axonics Sacral Neuromodulation System.
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