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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMedtronic Altaviva System
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantMedtronic Neuromodulation
7000 Central Ave. NE
Ms Rce480
Minneapolis, MN 55432
PMA NumberP240011
Date Received04/04/2024
Decision Date09/18/2025
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05226286
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Medtronic Altaviva System is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 
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