PMA P130008S124
- Device
- INSPIRE II UPPER AIRWAY STIMULATOR
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S124
- Product code
- MNQ
- Decision date
- 2026-02-06
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- labeling changes to include 3.0T magnetic resonance imaging (MRI) scanning conditions.
Current openFDA PMA Record#
- Device
- INSPIRE II UPPER AIRWAY STIMULATOR
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S124
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-02-06
- Decision code
- APPR
- Date received
- 2025-04-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- labeling changes to include 3.0T magnetic resonance imaging (MRI) scanning conditions.