PMA P130008S058
- Device
- Inspire Implantable Pulse Generator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S058
- Product code
- MNQ
- Decision date
- 2020-09-16
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Change to the cleaning process of Model 3028 IPG involving the replacement of trichloroethylene with an alcohol-based solvent.
Current openFDA PMA Record#
- Device
- Inspire Implantable Pulse Generator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S058
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-09-16
- Decision code
- OK30
- Date received
- 2020-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the cleaning process of Model 3028 IPG involving the replacement of trichloroethylene with an alcohol-based solvent.