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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceVIRTIS SACRAL NEUROMODULATION SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantCirtec 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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