PMA P250013

Device: aura6000™ system
Applicant: LivaNova USA, Inc.
PMA number: P250013
Supplement: S002
Product code: MNQ
Decision date: 2026-06-18
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250013

Current openFDA PMA Record#

Device: aura6000™ system
Applicant: LivaNova USA, Inc.
PMA number: P250013
Supplement: S002
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-06-18
Decision code: APPR
Date received: 2026-05-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250013