Axonics Sacral Neuromodulation System
FDA premarket approval P190006/S071 · decided 2023-10-23
Approval details
- PMA number
- P190006
- Supplement
- S071
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-07-27
- Decision date
- 2023-10-23
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- This 180-day PMA supplement requested approval for expansion of the current MRI labeling to permit a 1.5T MRI scan on the 4101/5101 IPG connected to a tined lead with high impedance (a broken lead).
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