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The Tracker / March 2026 / P250013

PMA approved

aura6000 system

LivaNova USA, Inc. · Mar 18, 2026 · P250013

FDA approved the aura6000 system from LivaNova USA, Inc. on Mar 18, 2026 under P250013, an original premarket approval. The device falls under product code MNQ, Stimulator, Hypoglossal Nerve, Implanted, Apnea as a Class 3 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 25, 2025. The decision came 327 days later.

LivaNova USA, Inc. has one other decision in the tracker over the last 12 months: K250937 (Venous Return Cannulae).

Questions & Answers

What did FDA approve under P250013?

P250013 is the FDA PMA for aura6000 system, submitted by LivaNova USA, Inc.. FDA's decision date was Mar 18, 2026, under product code MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea).

Who makes the aura6000 system?

LivaNova USA, Inc., based in Houston, TX, is the applicant of record for P250013.

How long did the P250013 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Mar 18, 2026, 327 days later.

← All decisions in March 2026