PMA P250013
- Device
- aura6000™ system
- Applicant
- LivaNova USA, Inc.
- PMA number
- P250013
- Supplement
- S001
- Product code
- MNQ
- Decision date
- 2026-04-30
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval of the protocol for the New Enrollment post-approval study (PAS) 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
- S001
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-04-30
- Decision code
- APPR
- Date received
- 2026-03-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the New Enrollment post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order for P250013