Axonics Sacral Neuromodulation System
FDA premarket approval P190006/S025 · decided 2021-06-11
Approval details
- PMA number
- P190006
- Supplement
- S025
- 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
- 2020-11-04
- Decision date
- 2021-06-11
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the addition of "3T RF whole-body coil conditional MRI scans at MC 2 mode" labeling on the Axonics Sacral Neuromodulation System.
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