Axonics Sacral Neuromodulation System
FDA premarket approval P180046/S094 · decided 2025-02-03
Approval details
- PMA number
- P180046
- Supplement
- S094
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-11-06
- Decision date
- 2025-02-03
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- 3T MRI conditional labeling for patients who have the Axonics SNM System with (1) a broken tined lead with high impedance or (2) an existing Axonics or Medtronic SNM lead fragment.
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