Axonics Sacral Neuromodulation System
FDA premarket approval P190006 · decided 2019-09-06
Approval details
- PMA number
- P190006
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-03-04
- Decision date
- 2019-09-06
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the Axonics Sacral Neuromodulation System. This device is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
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