PMA P130008
- Device
- Model 3150 Implantable Pulse Generator (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S093
- Product code
- MNQ
- Decision date
- 2026-07-10
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Addition of a new supplier for a component of the PCBA of model 3150 IPG
Current openFDA PMA Record#
- Device
- Model 3150 Implantable Pulse Generator (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S140
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-07-10
- Decision code
- APPR
- Date received
- 2026-04-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier for a component of the PCBA of model 3150 IPG