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The Tracker / September 2025 / P240011

PMA approved

Medtronic Altaviva System

Medtronic Neuromodulation · Sep 18, 2025 · P240011

FDA approved the Medtronic Altaviva System from Medtronic Neuromodulation on Sep 18, 2025 under P240011, an original premarket approval. The device falls under product code QPT, Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 4, 2024. The decision came 532 days later.

This is the only decision on file for Medtronic Neuromodulation in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P240011?

P240011 is the FDA PMA for Medtronic Altaviva System, submitted by Medtronic Neuromodulation. FDA's decision date was Sep 18, 2025, under product code QPT (Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence).

Who makes the Medtronic Altaviva System?

Medtronic Neuromodulation, based in Minneapolis, MN, is the applicant of record for P240011.

How long did the P240011 review take?

FDA received the submission on Apr 4, 2024 and issued its decision on Sep 18, 2025, 532 days later.

← All decisions in September 2025