PMA P130008S026
- Device
- Inspire Medical System Model 3028 Hybrid Process
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S026
- Product code
- MNQ
- Decision date
- 2017-06-09
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Changes to the weld blocks/solder paste used in the manufacture of the Model 3028 IPG.
Current openFDA PMA Record#
- Device
- Inspire Medical System Model 3028 Hybrid Process
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S026
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2017-06-09
- Decision code
- OK30
- Date received
- 2017-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the weld blocks/solder paste used in the manufacture of the Model 3028 IPG.