PMA P130008S028
- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S028
- Product code
- MNQ
- Decision date
- 2017-12-08
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Changes to update to software version 1.1.9 of the final functional test system for the Model 3028 IPG.
Current openFDA PMA Record#
- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S028
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2017-12-08
- Decision code
- OK30
- Date received
- 2017-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to update to software version 1.1.9 of the final functional test system for the Model 3028 IPG.