| Device | VIRTIS SACRAL NEUROMODULATION SYSTEM |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | Cirtec Medical Corporation9200 Xylon Avenue Nbrooklyn Park, MN 55445 PMA NumberP170001 Date Received01/17/2017 Decision Date01/11/2023 Product Code EZW Advisory Committee Gastroenterology/Urology Expedited Review Granted? No |
| Date Received | 2017-01-17 |
| Decision Date | 2023-01-11 |
| PMA | P170001 |
| Supplement | S |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cirtec Medical Corporation 9200 Xylon Avenue N brooklyn Park, MN 55445 PMA NumberP170001 Date Received01/17/2017 Decision Date01/11/2023 Product Code EZW Advisory Committee Gastroenterology/Urology Expedited Review Granted? No Combination ProductNo Approval Order 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. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170001 | Original Filing |