PMA P130008S127
- Device
- MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S127
- Product code
- MNQ
- Decision date
- 2025-07-21
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- manufacturing change to the Theta 1 ASIC component of the IPG
Current openFDA PMA Record#
- Device
- MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S127
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2025-07-21
- Decision code
- OK30
- Date received
- 2025-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing change to the Theta 1 ASIC component of the IPG