PMA P130008S135
- Device
- Model 3028 Connector Block Laser Weld Inspection Update
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S135
- Product code
- MNQ
- Decision date
- 2026-02-23
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Model 3028 IPG header laser weld visual inspection
Current openFDA PMA Record#
- Device
- Model 3028 Connector Block Laser Weld Inspection Update
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S135
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-02-23
- Decision code
- OK30
- Date received
- 2026-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Model 3028 IPG header laser weld visual inspection