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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.
 
DeviceMedtronic Altaviva System
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantMedtronic Neuromodulation
7000 Central Ave. NE
Ms Rce480
Minneapolis, MN 55432
PMA NumberP240011
Supplement NumberS004
Date Received11/21/2025
Decision Date12/19/2025
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05226286
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The protocol modifications include the addition of quality-of-life, work productivity, mental health, and sexual health questionnaires. Additional revisions included changing "up to 30 institutions" to "approximately 30 institutions", requirements for appropriate investigator training, education, and experience, and updated language regarding the 6-month washout period for botulinum toxin therapy and sacral neuromodulation.
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