PMA P130008S037
- Device
- Model 3028 Implantable Pulse Generator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S037
- Product code
- MNQ
- Decision date
- 2019-01-24
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for a new potting epoxy within the Model 3028 IPG.
Current openFDA PMA Record#
- Device
- Model 3028 Implantable Pulse Generator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S037
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-01-24
- Decision code
- APPR
- Date received
- 2018-10-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new potting epoxy within the Model 3028 IPG.