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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™ Implantable Neurostimulator
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantMedtronic Neuromodulation
7000 Central Ave. NE
Ms Rce480
Minneapolis, MN 55432
PMA NumberP240011
Supplement NumberS002
Date Received09/22/2025
Decision Date10/21/2025
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of a manufacturing site change for Heraeus Medical Components and the addition of Electrical Discharge Machining (EDM) to the manufacturing process of feedthrough pins, process updates to feedthrough and hermetic testing operations including leak testing, implementation of a new sputter monitor visual inspection for the presence of unintended gold material between the feedthrough component and the tri-metal sputtered layer.
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