VIRTIS SACRAL NEUROMODULATION SYSTEM
FDA premarket approval P170001 · decided 2023-01-11
Approval details
- PMA number
- P170001
- Trade name
- VIRTIS SACRAL NEUROMODULATION SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Cirtec Medical Corporation
- Date received
- 2017-01-17
- Decision date
- 2023-01-11
- Days to decision
- 2185 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Brooklyn Park, MN
- Statement
- Approval for the Virtis Sacral Neuromodulation System. This 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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