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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAltaviva™
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantMedtronic Neuromodulation
7000 Central Ave. NE
Ms Rce480
Minneapolis, MN 55432
PMA NumberP240011
Supplement NumberS010
Date Received02/19/2026
Decision Date07/13/2026
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of updated labeling for the Altaviva™ system to incorporate the 24-month results from the TITAN 2 clinical study.
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