Axonics Sacral Neuromodulation System
FDA premarket approval P180046 · decided 2019-11-13
Approval details
- PMA number
- P180046
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-12-06
- Decision date
- 2019-11-13
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the Axonics Sacral Neuromodulation System. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
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