VIRTIS SACRAL NEUROMODULATION SYSTEM

FDA Premarket Approval P170001

Pre-market Approval Supplement Details

DeviceVIRTIS SACRAL NEUROMODULATION SYSTEM
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantCirtec 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 Received2017-01-17
Decision Date2023-01-11
PMAP170001
SupplementS
Product CodeEZW 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination ProductNo
Applicant AddressCirtec 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:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P170001Original Filing

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