Axonics Sacral Neuromodulation System
FDA premarket approval P180046/S054 · decided 2023-02-07
Approval details
- PMA number
- P180046
- Supplement
- S054
- 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
- 2022-04-15
- Decision date
- 2023-02-07
- Days to decision
- 298 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for a labeling expansion to '1.5T MRI conditional' for the Axonics Sacral Neuromodulation System in two clinical scenarios: 1) abandoned lead fragment (i.e., no implanted pulse generator in the body); and 2) a broken lead connected with an intact, rechargeable, implanted pulse generator.
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